clinical biostatistician

Department Of Food & Agriculture

<p></p><div><div><div><div><div><div><div><div><div><div><div><div>Conduct biostatistical analyses (using statistical analysis software such as SAS, R, STATA, Excel, etc.) on qualitative and quantitative data collected by the program, including from studies of various designs, in order to assess and identify trends in antimicrobial use, antimicrobial resistance, and associated risk factors<br>
<ul><li>
</li>
Provide analytical feedback on, and support development of, research study designs and instruments used to evaluate and report on antimicrobial use and resistance, and to compare program results with those of other entities, including State and Federal efforts<br>
<li>
</li>
Research additional analytical methodologies, including risk assessment strategies, that may contribute to a better understanding of antimicrobial drug use practices and the potential impact of antimicrobial drug use on antimicrobial resistance<br>
<li>
</li>
Oversee and manage contracted research projects with external entities, such as universities, including: developing knowledge base pertaining to livestock industries relevant to specific projects, monitoring project progress, working with contractors to resolve issues as they arise, evaluating project performance, making recommendations to senior management, and conducting presentations or briefings on project outcomes<br>
<li>
</li><li>
Evaluate the adequacy of existing and planned surveillance studies and, with guidance from the Research Scientist Supervisor II and Veterinarian Specialist, design supplemental monitoring projects as needed to meet program requirements and goals</li></ul><br>
<div><br>
<b>Candidates may perform these essential functions with or without reasonable accommodation.</b></div><p>
You will find additional information about the job in the <b>Duty Statement</b>.</p>
</div><p></p><div><p>Working Conditions</p>
<p></p><div>The duties of this position are mostly conducted indoors; however, the incumbent may occasionally be required to work outside and under difficult conditions.</div><div><br>
Travel (including nights, weekends, and holidays) for extensive periods may be required for meetings and events as well as during an emergency response. During emergency response periods, duties may require working long shifts at hours other than the normal work hours.</div><div><br>
Regular or recurring telework may occur as part of the incumbent&rsquo;s ongoing regular schedule in accordance with CDFAs Telework Policy. A complete list of working conditions can be found in the Duty Statement.</div>
</div></div><p></p><div><div><p>Minimum Requirements</p>
You will find the Minimum Requirements in the Class Specification.<ul><li>
RESEARCH SCIENTIST I (EPIDEMIOLOGY/BIOSTATISTICS)</li></ul>
</div><div><p>Additional Documents</p>
<ul><li>Job Application Package Checklist</li><li>
Duty Statement</li></ul>
</div></div><div><div><p>Position Details</p>
<div><div><div><b>Job Code #:</b> </div><div>JC-502602
</div></div><div><div><b>Position #(s):</b>
</div><div><div>014-118-5577-002</div>
</div></div><div><div><div><b>Working Title:</b> </div><div><b>Research Scientist</b>
</div></div></div><div><div><b>Classification:</b> </div><div>RESEARCH SCIENTIST I (EPIDEMIOLOGY/BIOSTATISTICS)
<div>$6,942.00 - $8,922.00
</div>New to State candidates will be hired into the minimum salary of the classification or minimum of alternate range when applicable.
</div></div><div></div><div><div><b># of Positions:</b> </div><div>1
</div></div><div><div><b>Work Location:</b> </div><div>Sacramento County
</div></div><div><div><b>Telework:</b> </div><div>Hybrid
</div></div><div><div><b>Job Type:</b> </div><div>Permanent, Full Time
</div></div></div></div><div><p>Department Information</p>
<div><div>Antimicrobial Use and Stewardship (AUS) is the statewide program intended to promote judicious use of antimicrobial drugs in livestock and other actions that will slow the development of resistant bacteria associated with animal agriculture. The program gathers data and develops studies related to medically important antimicrobial sales and usage in livestock, livestock management practices and animal health outcomes, and antibiotic resistance in bacteria associated with animal agriculture. Additionally, AUS works with universities and other subject matter experts to develop antimicrobial stewardship tools and promote animal husbandry practices that mitigate the development of antimicrobial resistance while maintaining animal health.</div>
</div></div></div><div></div><div><div><p>Special Requirements</p>
<div><ul><li>The position(s) require(s) a valid California Drivers License (CDL). You must answer the questions addressing your CDL on your application. Ensure you provide your CDL number, class, expiration date, and any endorsements and/or restrictions.</li>
</ul></div><div><div>Incumbent must possess a bachelor&rsquo;s degree in Epidemiology/Biostatistics Science or a closely related field and one year of research experience in a field relevant to the stated specialty. (One year towards completion of an advanced degree of the stated specialty or a closely related field may be substituted for this experience.) The incumbent must possess a valid California driver license subject to driving record approval.</div>
</div></div><div><p>Application Instructions</p>
<div><p>Completed applications and all required documents must be received or postmarked by the Final Filing Date in order to be considered. Dates printed on Mobile Bar Codes, such as the Quick Response (QR) Codes available at the USPS, are not considered Postmark dates for the purpose of determining timely filing of an application.
</p>Final Filing Date: 1/15/2026
<p><b>Who May Apply</b></p>
<div>Individuals who are currently in the classification, eligible for lateral transfer, eligible for reinstatement, have list or LEAP eligibility, are in the process of obtaining list eligibility, or have SROA and/or Surplus eligibility (please attach your letter, if available). SROA and Surplus candidates are given priority; therefore, individuals with other eligibility may be considered in the event no SROA or Surplus candidates apply.
<br>
<br>
Applications will be screened and only the most qualified applicants will be selected to move forward in the selection process. Applicants must meet the Minimum Qualifications stated in the Classification Specification(s).
</div><p><b>How To Apply</b></p>
<div>Complete Application Packages (including your Examination/Employment Application (STD 678) and applicable or required documents) must be submitted to apply for this Job Posting. Application Packages may be submitted electronically through your CalCareer Account at www.CalCareers.ca.gov. When submitting your application in hard copy, a completed copy of the Application Package listing must be included. If you choose to not apply electronically, a hard copy application package may be submitted through an alternative method listed below:<br>
<div><p><b>Address for Mailing Application Packages</b></p>
<p>You may submit your application and any applicable or required documents to:</p><br>
<div></div><div><div><div>Department of Food &amp; Agriculture
</div><div>Attn: Human Resource Branch JC-502602
</div><div>1220 N Street, Room 242
</div><div></div><div>Sacramento, CA 95814
</div></div></div></div><div><p><b>Address for Drop-Off Application Packages</b></p>
<p>You may drop off your application and any applicable or required documents at:</p><br>
<div></div><div><div><div><div>Department of Food &amp; Agriculture
</div><div></div><div>Human Resource Branch JC-502602
</div><div>1220 N Street, Room 242
</div><div></div><div>Sacramento, CA 95814
</div><div>ELECTRONIC APPLICATION IS PREFERRED. All mail or drop-off applications must include JC-502602
</div><div>08:00 AM - 05:00 PM
</div></div></div></div></div></div><p><b>Required Application Package Documents</b></p>
<p>The following items are required to be submitted with your application. Applicants who do not submit the required items timely may not be considered for this job:
</p><ul><li>Current version of the State Examination/Employment Application STD Form 678 (when not applying electronically), or the Electronic State Employment Application through your Applicant Account at www.CalCareers.ca.gov. All Experience and Education relating to the Minimum Qualifications listed on the Classification Specification should be included to demonstrate how you meet the Minimum Qualifications for the position.</li>
<li>Resume is required and must be included.</li>
<li>Degree and/or School Transcripts</li>
</ul></div>Applicants requiring reasonable accommodations for the hiring interview process must request the necessary accommodations if scheduled for a hiring interview. The request should be made at the time of contact to schedule the interview. Questions regarding reasonable accommodations may be directed to the EEO contact listed on this job posting.
</div></div></div><div><p>Desirable Qualifications</p>
<div>In addition to evaluating each candidate's relative ability, as demonstrated by quality and breadth of experience, the following factors will provide the basis for competitively evaluating each candidate:<br>
</div><div><div><br>
Under the supervision of the Research Scientist Supervisor II, and leadership of the Veterinarian (Specialist) for Surveys and Studies, the Research Scientist I (RSI) helps to design and implement studies, compile data, perform biostatistical analysis of programmatic information, develop reports, and draw conclusions from research investigations.</div><div><br>
The incumbent must be able to assist senior scientists with research studies, field trials, and investigations; analyze situations accurately and make appropriate decisions using sound scientific and biostatistical theories, principles, and methods that lead to effective and reliable recommendations; work independently to complete assigned work; work effectively with other team members on program projects and investigations; work well under pressure; meet required deadlines; take effective actions; collaborate with Federal, State, local, university, and other entities in the discharge of program activities; and establish and maintain effective working relationships with associates, stakeholders, decision-makers, and the general public.</div>
</div></div><div><p>Benefits</p>
<div>Benefit information can be found on the CalHR website and the CalPERS website.<br>
More than two weeks of paid vacation time within the first year of service, sick leave and paid holidays.<br>
<ul><li>
</li>
A benefits package that includes medical, dental, and vision insurance, a CalPERS pension, opportunities to create retirement savings through a 401(k) or 457 plan, and the opportunity to receive health insurance in retirement.<br>
<li>
</li>
On-the-job training and paid professional development days.<br>
<li>
</li>
The ability to contribute to the success of a first-in-the-nation program and the opportunity to learn and collaborate with local, state, and federal leaders.<br>
<li>
</li><li>
An office environment that supports a balanced lifestyle, flexible telework opportunities, and opportunities for in-state and out-of-state travel on assignment or to attend meetings/conferences in-person or virtually, depending on opportunity, availability, and staff enthusiasm.</li></ul>
</div></div><div><p>Contact Information</p>
<div><p>The Hiring Unit Contact is available to answer questions regarding the position or application process.
</p><p><b>Hiring Unit Contact:
</b><br>
Fernando Valenzuela<br>
(916) 576-0205<br>
fernando.valenzuela@cdfa.ca.gov
</p><div><p>Please direct requests for Reasonable Accommodations to the interview scheduler at the time the interview is being scheduled. You may direct any additional questions regarding Reasonable Accommodations or Equal Employment Opportunity for this position(s) to the Department's EEO Office.
</p><b>EEO Contact:</b><br>
Office of Civil Rights<br>
(916) 617-0090<br>
Civil_Rights@cdfa.ca.gov
</div><p>California Relay Service: 1-800-735-2929 (TTY), 1-800-735-2922 (Voice) TTY is a Telecommunications Device for the Deaf, and is reachable only from phones equipped with a TTY Device.
</p></div></div><div><p>Hard Copy Applications:</p>
<p></p><div>If you are dropping off or mailing in your application, please use the Examination/Employment Application, STD 678 Revised 6/2024 version.</div>
</div><p></p><div><p>Additional Information:</p>
<p></p>Please do not include any confidential information such as social security number, marital status, ethnicity, age, salary or disability information on any of the documentation uploaded with your online application.<br>
<ul><li>
</li>
If the classification you are applying for has an education requirement, transcripts will be required to verify you meet the minimum qualifications of the classification. Please be sure to redact any confidential information before uploading your transcripts.<br>
<li>
</li>
Upon hire you may be required to provide official sealed transcripts or an original degree or certificate.<br>
<li>
</li>
Applicants with foreign degrees may be asked to provide an official foreign transcript evaluation which indicates course work is equivalent to a degree from an accredited U.S. College or University.<br>
<li>
</li><li><b>
This position may require a medical clearance.</b><br>
</li><li><b>
Per CCR 249.3, this job control may be used to fill subsequent vacancies.</b></li></ul>
</div><p></p><div><div><p>Equal Opportunity Employer</p>
<p>The State of California is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation.
</p><p>It is an objective of the State of California to achieve a drug-free work place. Any applicant for state employment will be expected to behave in accordance with this objective because the use of illegal drugs is inconsistent with the law of the State, the rules governing Civil Service, and the special trust placed in public servants.</p></div></div></div></div></div></div></div></div></div></div></div><div></div>

RESEARCH SCIENTIST I (EPIDEMIOLOGY/BIOSTATISTICS)

The IMA Group

<div><div><h2 class="jobSectionHeader"><b>Clinical Research Coordinator &ndash; Austin, TX</b></h2><div>
(<b>Clinical Research - Research Coordinator - Research Assistant - Clinical Research Associate</b>)</div><div>
</div><div>
Join <b>IMA Clinical Research</b> as a <b>Clinical Research Coordinator</b> and help drive innovative <b>clinical research</b> studies that improve patient outcomes. This role is ideal for candidates experienced in <b>Research</b>, <b>Research Coordination</b>, <b>Clinical Research Associate</b> work, or <b>Research Assistant</b> responsibilities.</div><h3 class="jobSectionHeader"><b>
What You&rsquo;ll Do</b></h3></div><ul><li>
Support and coordinate clinical research trials from start to finish</li><li>
Guide patients through study visits and research procedures</li><li>
Work closely with investigators, sponsors, labs, and monitors</li><li>
Complete blood draws and clinical tasks</li><li>
Maintain accurate research documentation (ALCOA)</li></ul><div><h3 class="jobSectionHeader"><b>
What We&rsquo;re Looking For</b></h3></div><ul><li>
At least 2 years of <b>clinical research</b> experience (required)</li><li>
Phlebotomy experience (required)</li><li>
Bachelor&rsquo;s degree; Master&rsquo;s or CCRC a plus</li><li>
Strong organization skills and ability to manage multiple research studies</li></ul><div><h3 class="jobSectionHeader"><b>
What We Offer</b></h3></div><ul><li>
Fast-paced clinical research environment</li><li>
No on-call work</li><li>
Tuition support &amp; student loan assistance</li><li>
Medical, dental, vision, 401(k) match, PTO, holidays</li></ul><div><div>
</div><div>
Join our growing <b>Clinical Research</b> team and build your career as a <b>Clinical Research Coordinator</b>, <b>Research Coordinator</b>, <b>Clinical Research Associate</b>, or <b>Research Assistant</b>.</div></div><div>
</div><div></div><div><b><i>The IMA Group is an Affirmative Action/Equal Opportunity Employer</i></b>
</div><div></div><div>Our Government Services Division supports local, state, and federal agencies and delivers professional and objective medical and psychological examinations as well as ancillary services. Our Payer Services Division meets the evaluation and screening needs of Carriers, TPAs, Public Entities and Employers and includes behavioral health and physical medicine specialty services, working with a wide range of organizations within the workers' compensation, disability, liability, and auto markets. Our Clinical Research Division performs all types of Phase II-IV clinical trials in multiple therapeutic areas through a flexible nationwide network of site locations and virtual capabilities.
</div><div></div><div>#LI-EG1 #LI-ONSITE</div></div>

Clinical Research Coordinator - Growing Clinical Research Team - Austin, TX

Beacon Hill

<div>
 <p>
  <strong>
   What You&rsquo;ll Do
  </strong>
 </p>
 <p>
  In this role, you will contribute to the clinical development of early‑stage oncology programs and support studies across multiple phases. Responsibilities may include, but are not limited to:
 </p>
 <ul>
  <li>
   Developing clinical development concepts and plans in collaboration with clinical leadership, with an emphasis on early oncology assets.
  </li>
  <li>
   Drafting protocol synopses, full study protocols, and protocol amendments.
  </li>
  <li>
   Preparing and reviewing informed consent forms and evaluating site‑specific ICF submissions.
  </li>
  <li>
   Partnering with Clinical Operations on site selection, study start‑up, and ongoing communication.
  </li>
  <li>
   Contributing to the creation and maintenance of clinical sections of investigator brochures, including coordinating initial versions and annual updates.
  </li>
  <li>
   Writing and/or reviewing clinical and safety content for regulatory submissions (e.g., global marketing applications).
  </li>
  <li>
   Representing clinical/medical perspectives on study teams and supporting clinical leadership in strategic decision‑making.
  </li>
  <li>
   Participating in clinical sub‑team activities.
  </li>
  <li>
   Reviewing safety data, data listings, and serious adverse event information to support ongoing study evaluation.
  </li>
  <li>
   Contributing to or leading the authorship of clinical study reports and publications.
  </li>
  <li>
   Creating study‑ or program‑related presentation materials for internal and external audiences.
  </li>
  <li>
   Providing training to internal teams, CRO partners, and study site personnel on therapeutic area topics, program background, and study protocols.
  </li>
  <li>
   Supporting and participating in advisory boards and expert consultations.
  </li>
  <li>
   Conducting therapeutic area research, competitive landscape assessments, and indication‑specific analyses.
  </li>
  <li>
   Establishing and maintaining relationships with key investigators and thought leaders.
  </li>
  <li>
   Supporting interactions with global health authorities, including preparing responses to inspection findings and audit observations.
  </li>
  <li>
   Assisting with regulatory updates and submission‑related clinical deliverables.
  </li>
  <li>
   Supporting medical monitoring activities for Phase 2 or 3 clinical trials, ensuring patient safety and contributing guidance across study design, execution, and reporting.
  </li>
 </ul>
 <p>
  Additional contributions may include presenting study outcomes to internal committees, external scientific groups, or advisory bodies; contributing to scientific congress presentations; and supporting publication activities. Program‑level responsibilities may involve authoring or reviewing clinical summaries, overviews, risk management materials, periodic safety updates, and labeling sections.
 </p>
 <p>
  <strong>
   Requirements
  </strong>
 </p>
 <ul>
  <li>
   Bachelor&rsquo;s degree with substantial clinical oncology expertise gained through prior clinical development experience.
  </li>
  <li>
   Advanced degree or clinical qualification in oncology (e.g., Master&rsquo;s, MD, PharmD, PhD, or equivalent) preferred.
  </li>
  <li>
   Minimum of 4 years of industry experience in oncology drug development.
  </li>
  <li>
   Prior involvement in clinical development programs, ideally across all study phases from initiation through reporting.
  </li>
  <li>
   Experience working with small‑molecule oncology therapeutics is advantageous.
  </li>
  <li>
   Strong competency in protocol design, clinical data interpretation, and medical monitoring.
  </li>
  <li>
   Experience evaluating safety data and adverse events in therapeutic trials is preferred.
  </li>
  <li>
   Solid understanding of Good Clinical Practice (GCP) and regulatory expectations.
  </li>
  <li>
   Excellent written and verbal communication skills.
  </li>
  <li>
   Ability to work effectively in a fast‑paced, evolving environment
  </li>
 </ul>
</div>


Clinical Scientist Director

IQVIA

<div><div><div>Abington Township, United States of America | Full time | Home-based | R1520965</div><div><div><b>
Job available in additional locations</b></div></div></div><p></p><div><div><i><br>
IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative treatments to patients faster.</i></div><div>
Job Overview<br>
Associate Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients&rsquo; lives by bringing new drugs to the market faster. The Associate Clinical Lead is a member of the core project team responsible for clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices. Associate Clinical Leads partner with Project Leaders and other functional teams to secure delivery requirements are met at all times.<br>
<br>
Essential Functions<br>
<ul><li>Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).</li><li>Accountable for meeting projects&rsquo; recruitment targets and ensuring appropriate recruitment strategies are in place.</li><li>Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project&rsquo;s lifecycle.</li><li>Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.</li><li>Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.</li><li>Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.</li><li>Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.</li><li>Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.</li><li>Conduct regular team meetings and communicate appropriately to achieve objectives.</li><li>Support professional development by providing feedback to clinical team line managers on performance relative to project tasks.</li><li>May work as the sole Clinical Lead on projects with 1-2 service lines and single/few countries or alongside more senior Clinical Leads to deliver large, global trials.;</li><li>May attend site visits as applicable in support of project delivery.</li></ul><br>
Qualifications<br>
<ul><li>Bachelor's Degree Bachelor's Degree in health care or other scientific discipline required</li><li>Requires 3 years clinical research/monitoring experience or equivalent combination of education, training and experience.;</li><li>Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.;</li><li>Requires broad protocol knowledge and therapeutic knowledge.;</li><li>Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates.</li><li>Requires basic understanding of project finances.;</li><li>Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e., International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.;</li><li>Communication - Strong written and verbal communication skills including good command of English language.</li><li>Problem solving - Problem solving skills.</li><li>Organization - Planning, time management and prioritization skills.</li><li>Prioritization - Ability to handle conflicting priorities.</li><li>Quality - Attention to detail and accuracy in work.</li><li>Results-oriented approach to work delivery and output.; and PowerPoint.;</li><li>IT skills - Good software and computer skills, including Microsoft Office applications including but not limited to Microsoft Word, Excel and PowerPoint.;</li><li>Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients.</li><li>Cross-collaboration - Ability to work across cultures and geographies with a high awareness and understanding of cultural differences.</li><li>Effective communication - Ability to influence without authority.</li><li>IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).</li></ul></div><div>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</div><div>
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe</div>
The potential base pay range for this role, when annualized, is $68,400.00 - $171,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.</div></div><div></div>

Clinical Trial Manager I, IQVIA Biotech

<div><div><div>New City, United States of America | Full time | Home-based | R1520965</div><div><div><b>
Job available in additional locations</b></div></div></div><p></p><div><div><i><br>
IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative treatments to patients faster.</i></div><div>
Job Overview<br>
Associate Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients&rsquo; lives by bringing new drugs to the market faster. The Associate Clinical Lead is a member of the core project team responsible for clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices. Associate Clinical Leads partner with Project Leaders and other functional teams to secure delivery requirements are met at all times.<br>
<br>
Essential Functions<br>
<ul><li>Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).</li><li>Accountable for meeting projects&rsquo; recruitment targets and ensuring appropriate recruitment strategies are in place.</li><li>Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project&rsquo;s lifecycle.</li><li>Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.</li><li>Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.</li><li>Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.</li><li>Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.</li><li>Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.</li><li>Conduct regular team meetings and communicate appropriately to achieve objectives.</li><li>Support professional development by providing feedback to clinical team line managers on performance relative to project tasks.</li><li>May work as the sole Clinical Lead on projects with 1-2 service lines and single/few countries or alongside more senior Clinical Leads to deliver large, global trials.;</li><li>May attend site visits as applicable in support of project delivery.</li></ul><br>
Qualifications<br>
<ul><li>Bachelor's Degree Bachelor's Degree in health care or other scientific discipline required</li><li>Requires 3 years clinical research/monitoring experience or equivalent combination of education, training and experience.;</li><li>Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.;</li><li>Requires broad protocol knowledge and therapeutic knowledge.;</li><li>Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates.</li><li>Requires basic understanding of project finances.;</li><li>Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e., International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.;</li><li>Communication - Strong written and verbal communication skills including good command of English language.</li><li>Problem solving - Problem solving skills.</li><li>Organization - Planning, time management and prioritization skills.</li><li>Prioritization - Ability to handle conflicting priorities.</li><li>Quality - Attention to detail and accuracy in work.</li><li>Results-oriented approach to work delivery and output.; and PowerPoint.;</li><li>IT skills - Good software and computer skills, including Microsoft Office applications including but not limited to Microsoft Word, Excel and PowerPoint.;</li><li>Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients.</li><li>Cross-collaboration - Ability to work across cultures and geographies with a high awareness and understanding of cultural differences.</li><li>Effective communication - Ability to influence without authority.</li><li>IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).</li></ul></div><div>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</div><div>
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe</div>
The potential base pay range for this role, when annualized, is $68,400.00 - $171,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.</div></div><div></div>

<div><div><div>Berkeley, United States of America | Full time | Home-based | R1520965</div><div><div><b>
Job available in additional locations</b></div></div></div><p></p><div><div><i><br>
IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative treatments to patients faster.</i></div><div>
Job Overview<br>
Associate Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients&rsquo; lives by bringing new drugs to the market faster. The Associate Clinical Lead is a member of the core project team responsible for clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices. Associate Clinical Leads partner with Project Leaders and other functional teams to secure delivery requirements are met at all times.<br>
<br>
Essential Functions<br>
<ul><li>Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).</li><li>Accountable for meeting projects&rsquo; recruitment targets and ensuring appropriate recruitment strategies are in place.</li><li>Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project&rsquo;s lifecycle.</li><li>Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.</li><li>Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.</li><li>Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.</li><li>Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.</li><li>Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.</li><li>Conduct regular team meetings and communicate appropriately to achieve objectives.</li><li>Support professional development by providing feedback to clinical team line managers on performance relative to project tasks.</li><li>May work as the sole Clinical Lead on projects with 1-2 service lines and single/few countries or alongside more senior Clinical Leads to deliver large, global trials.;</li><li>May attend site visits as applicable in support of project delivery.</li></ul><br>
Qualifications<br>
<ul><li>Bachelor's Degree Bachelor's Degree in health care or other scientific discipline required</li><li>Requires 3 years clinical research/monitoring experience or equivalent combination of education, training and experience.;</li><li>Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.;</li><li>Requires broad protocol knowledge and therapeutic knowledge.;</li><li>Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates.</li><li>Requires basic understanding of project finances.;</li><li>Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e., International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.;</li><li>Communication - Strong written and verbal communication skills including good command of English language.</li><li>Problem solving - Problem solving skills.</li><li>Organization - Planning, time management and prioritization skills.</li><li>Prioritization - Ability to handle conflicting priorities.</li><li>Quality - Attention to detail and accuracy in work.</li><li>Results-oriented approach to work delivery and output.; and PowerPoint.;</li><li>IT skills - Good software and computer skills, including Microsoft Office applications including but not limited to Microsoft Word, Excel and PowerPoint.;</li><li>Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients.</li><li>Cross-collaboration - Ability to work across cultures and geographies with a high awareness and understanding of cultural differences.</li><li>Effective communication - Ability to influence without authority.</li><li>IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).</li></ul></div><div>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</div><div>
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe</div>
The potential base pay range for this role, when annualized, is $68,400.00 - $171,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.</div></div><div></div>

<div><div><div>Bloomington, United States of America | Full time | Home-based | R1520965</div><div><div><b>
Job available in additional locations</b></div></div></div><p></p><div><div><i><br>
IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative treatments to patients faster.</i></div><div>
Job Overview<br>
Associate Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients&rsquo; lives by bringing new drugs to the market faster. The Associate Clinical Lead is a member of the core project team responsible for clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices. Associate Clinical Leads partner with Project Leaders and other functional teams to secure delivery requirements are met at all times.<br>
<br>
Essential Functions<br>
<ul><li>Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).</li><li>Accountable for meeting projects&rsquo; recruitment targets and ensuring appropriate recruitment strategies are in place.</li><li>Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project&rsquo;s lifecycle.</li><li>Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.</li><li>Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.</li><li>Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.</li><li>Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.</li><li>Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.</li><li>Conduct regular team meetings and communicate appropriately to achieve objectives.</li><li>Support professional development by providing feedback to clinical team line managers on performance relative to project tasks.</li><li>May work as the sole Clinical Lead on projects with 1-2 service lines and single/few countries or alongside more senior Clinical Leads to deliver large, global trials.;</li><li>May attend site visits as applicable in support of project delivery.</li></ul><br>
Qualifications<br>
<ul><li>Bachelor's Degree Bachelor's Degree in health care or other scientific discipline required</li><li>Requires 3 years clinical research/monitoring experience or equivalent combination of education, training and experience.;</li><li>Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.;</li><li>Requires broad protocol knowledge and therapeutic knowledge.;</li><li>Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates.</li><li>Requires basic understanding of project finances.;</li><li>Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e., International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.;</li><li>Communication - Strong written and verbal communication skills including good command of English language.</li><li>Problem solving - Problem solving skills.</li><li>Organization - Planning, time management and prioritization skills.</li><li>Prioritization - Ability to handle conflicting priorities.</li><li>Quality - Attention to detail and accuracy in work.</li><li>Results-oriented approach to work delivery and output.; and PowerPoint.;</li><li>IT skills - Good software and computer skills, including Microsoft Office applications including but not limited to Microsoft Word, Excel and PowerPoint.;</li><li>Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients.</li><li>Cross-collaboration - Ability to work across cultures and geographies with a high awareness and understanding of cultural differences.</li><li>Effective communication - Ability to influence without authority.</li><li>IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).</li></ul></div><div>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</div><div>
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe</div>
The potential base pay range for this role, when annualized, is $68,400.00 - $171,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.</div></div><div></div>

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