clinical trial data manager

TYG Consultant's

<p><b>Clinical Data Manager</b></p><p><b>100 percent onsite-Location: Maple Grove, MN</b></p><p><b>Hours: 8:00am-4:00 PM</b></p><p><b>Duration: This is a 6-month contract with potential to extend highly likely</b></p><p><b>Main purpose of role</b></p><p><b>Summarize the main purpose of the role.</b></p><p>The Clinical Data Manager is responsible for managing the development, documentation, and execution of risk-based quality management systems, as described in the risk assessment, data management plan, and site and central monitoring plans.</p><p>As the customer-face of Data Review and its primary liaison with the therapy group, the Clinical Data Manager's therapy-specific knowledge ensures alignment to customer definitions of criticality, and informs review and analysis of study data.</p><p><b>Main responsibilities</b></p><ul><li>Identification of study specific risks to study conduct and human subject safety; analysis of risks; development and implementation of mitigation strategies.</li><li>Review of study data to detect anticipated and unanticipated issues related to trial data completeness and quality.</li><li>Facilitate multi-stakeholder discussions to review findings, evaluate impact and develop action plans for correction and continued monitoring.</li><li>Conduct Central Monitoring activities, as described in Central Monitoring Plan.</li><li>Direct all data cleaning activity related to assigned studies.</li></ul><p><b>Qualifications</b></p><ul><li>Bachelors Degree (&plusmn; 16 years) Biology, Health Sciences, Mathematics, Computer Science, or equivalent.</li></ul><p><b>Experience/Background</b></p><ul><li>Minimum 3 years</li></ul><p><b>Experience Details</b></p><ul><li>3 years in clinical operations or healthcare related field.</li><li>Education and work experience in project management, life sciences and/or technical field.</li><li>Knowledge of data collection best practices for clinical trials.</li><li>Knowledge of global clinical operations.</li><li>Experience in consultative role, with Subject Matter Expertise, and effectively influencing a team decision to the desired outcome.</li><li>Proficient at the identification of risks in a process, evaluation of likelihood and impact, and the development of effective mitigation and monitoring strategies that are imperfect yet meet the business need.</li><li>Proficient in the translation of clinical trial requirements to the technical specifications required for effective data collection.</li><li>Skilled at making inferences and connections based on limited information, clearly describing the knowns, unknowns, and alternative explanations.</li><li>Intermediate project management skills; developing a multifaceted plan with complex dependencies and holding peers accountable to adherence to the plan while maintaining positive and collaborative relationships.</li><li>Intermediate therapy specific knowledge of anatomy, physiology, pathophysiology, therapy and device.</li></ul><p><b>Licenses and Certifications</b></p><ul><li>None required; Certified Clinical Data Manager (CCDM) or equivalent nice to have.</li></ul><p>Job Type: Contract</p><p>Pay: $42.00 - $44.00 per hour</p><p>Expected hours: 40 per week</p><p>Benefits:</p><ul><li>Health insurance</li></ul><p>Education:</p><ul><li>Bachelor's (Preferred)</li></ul><p>Experience:</p><ul><li>clinical data: 3 years (Preferred)</li><li>EDC (Electronic Data Capture): 3 years (Preferred)</li><li>central monitoring or risk-based monitoring: 3 years (Preferred)</li><li>pharma, medical device, CRO or healthcare industry: 3 years (Preferred)</li><li>overseeing clinical trial data: 3 years (Preferred)</li></ul><p>Ability to Commute:</p><ul><li>Maple Grove, MN 55311 (Preferred)</li></ul><p>Work Location: In person</p>

Clinical Data Manager (EDC/Clinical Operations/Central Monitoring) (Pharma/Healthcare)

Quest Diagnostics

<div><p><b>Clinical Trial Study Manager I - Seattle, WA, Monday to Friday, 8:00 AM to 5:00 PM</b></p>
<p><b>
Pay range: $90,500 - $162,950 / year</b><br>
Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation.</p>
<div><b>
Benefits Information:</b><br>
We are proud to offer best-in-class benefits and programs to support employees and their families in living healthy, happy lives. Our pay and benefit plans have been designed to promote employee health in all respects &ndash; physical, financial, and developmental. Depending on whether it is a part-time or full-time position, some of the benefits offered may include:<br>
<ul><li>Day 1 Medical, supplemental health, dental &amp; vision for FT employees who work 30+ hours</li><li>Best-in-class well-being programs</li><li>Annual, no-cost health assessment program Blueprint for Wellness&reg;</li><li>healthyMINDS mental health program</li><li>Vacation and Health/Flex Time</li><li>6 Holidays plus 1 &quot;MyDay&quot; off</li><li>FinFit financial coaching and services</li><li>401(k) pre-tax and/or Roth IRA with company match up to 5% after 12 months of service</li><li>Employee stock purchase plan</li><li>Life and disability insurance, plus buy-up option</li><li>Flexible Spending Accounts</li><li>Annual incentive plans</li><li>Matching gifts program</li><li>Education assistance through MyQuest for Education</li><li>Career advancement opportunities</li><li>and so much more!</li></ul><br>
</div><p>The Clinical Trials Study Manager 1 is primarily responsible for coordinating the execution of clinical trial projects, including managing the scope, timeline, and budget of assigned projects. This position may also have direct line management responsibility of junior-level study management team members. They will have indirect management responsibility of team members supporting clinical trial projects.</p><div>
<div><div><div>Quest Diagnostics honors our service members and encourages veterans to apply.<br>
<br>
While we appreciate and value our staffing partners, we do not accept unsolicited resumes from agencies. Quest will not be responsible for paying agency fees for any individual as to whom an agency has sent an unsolicited resume.<br>
<br>
Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.</div>
</div><br>
</div></div><ul><li>Review the contracted scope, budget, and timeline to develop a plan of action or multiple plans of action to successfully complete project.</li><li>
Coordinate with scientific and technical directors as the scientific leaders for the project.</li><li>
Coordinate with appropriate technical staff within the laboratory operations to ensure operational plan is achievable and appropriate resources are available for the scope.</li><li>
Coordinate with Director, Business Development throughout the life of the project to ensure scope, timeline and budget are well understood and also understand escalation path for communicating issues.</li><li>
Manage and own client relationship throughout the study</li><li>
Identify, track, and manage risks that may impact our ability to successfully complete the scope of the project in the timeline or budget available.</li><li>
Identify new or out of scope requests from customer and communicate with Business Development so contract modifications can be implemented.</li><li>
Maintain official project records from inception to completion including archiving.</li><li>
Ensure that contracted work is conducted within regulatory requirements (FDA, EMEA, GCLP).</li><li>
Develop overall project plan and maintain regular touch points to ensure that timelines are being met.</li><li>
Communicate with customer on regular operational items (project updates, scope alignment).</li><li>
Other duties as assigned.</li></ul><p><b>
Required Work Experience:</b></p><ul><li>
3-4 years of healthcare experience or equivalent education and experience.</li><li>
1-2 years of previous project management experience required.</li><li>
4-year degree is required.</li></ul><p><b>
Preferred Work Experience:</b></p><ul><li>
1-2 years of previous laboratory experience preferred.</li><li>
Previous experience in a GXP environment preferred.</li></ul><p><b>
Physical and Mental Requirements:</b></p><ul><li>
Ability to sit for extended periods of time.</li><li>
Ability to stand for extended periods of time.</li><li>
Must regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds.</li><li>
Ability to use fine motor skills to operate office equipment.</li><li>
Ability to receive and comprehend instructions verbally and/or in writing.</li><li>
Ability to use logical reasoning for simple and complex problem-solving.</li></ul><p><b>
Knowledge:</b></p><ul><li>
N/A</li></ul><p><b>
Skills:</b></p><ul><li>
Excellent verbal and written communication skills.</li><li>
Exceptional interpersonal skills and business acumen.</li><li>
Strong organizational skills; very detail-oriented and a self-motivated problem solver.</li><li>
Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.</li></ul></div>

Clinical Trial Study Manager I

CenExel Clinical Research

<p></p><div><p><b>About Us:</b></p><br>
<p>
</p><p>Each of CenExel&rsquo;s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.</p><br>
<p></p>
<p>
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.</p><br>
<p></p>
<p><b>
Job Summary:
</b></p><p>Responsible for the management of clinical research studies and the personnel assigned to those studies, under the direction of the Clinical Director.</p><br>
<p></p>
<p><b>
Essential Responsibilities and Duties:</b></p>
<ul>
<li>Manages all assigned clinical staff.</li>
<li>Reads and understands assigned protocols and leads and interfaces on such protocols with the study staff to achieve successful execution within appropriate timeframes.</li>
<li>Conducts Site Qualification Visits, as assigned. Schedules and oversees Investigator Meeting arrangements, conducts initiation, study start-up, and team meetings. Oversees scheduling and conduct of monitor visits. Represents the clinical team during site visits.</li>
<li>Oversees preparation of, or personally prepares study-specific source documents for new protocols. Reviews and modifies sponsor-provided source documents, when necessary. Assists Study Coordinators in duties, as necessary.</li>
<li>On assigned protocols, assists to oversee delivery, shipment, inventory, storage, calibration and accountability of investigational products, supplies and equipment required to conduct clinical investigations.</li>
<li>Ensures optimum team function by assisting Clinical Research Coordinators with site start up, enrollment and study execution. Is present for first patient randomized on each study.</li>
<li>Fields protocol questions from Clinical Research Coordinators.</li>
<li>Acts as the project lead, liaising between sites, investigators, monitors, clinical research coordinators, physicians, laboratory, pharmacy staff, and other study team members. Assists with study in-services and other training needs as needed.</li>
<li>Oversees the following aspect of trials but is not limited to: Vendors, Client Satisfaction, Recruitment, Quality, Study Start-up and Trial Outcomes.</li>
<li>Monitoring the progress and completion of routine action items and ensuring timely follow-up.</li>
<li>Ensuring proper internal procedures are followed and documentation is obtained from coordinators for approval of retest, unscheduled visits, admits, AE treatments, etc.</li>
<li>Hires, trains, supervises, and evaluates personnel. Champions and enforces the strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site Working Practices, protocol, and company guidelines and policies. Retrains and implements corrective and preventative actions, as needed.</li>
<li>Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.</li></ul><br>
<p></p>
<p><b>
Education/Experience/Skills:</b></p>
<ul>
<li>Bachelor's degree in related field or equivalent experience is preferred.</li>
<li>Minimum of three years of Clinical Research Coordinator or equivalent experience.</li>
<li>Ability to independently coordinate and manage complex protocols and to lead, motivate and train a clinical research team.</li>
<li>Experience managing and leading staff and implementing personnel procedures.</li>
<li>Professional image, upholding the company vision in actions, demeanor, and appearance.</li>
<li>Must be able to effectively communicate verbally and in writing.</li></ul><br>
<p></p>
<p><b>
Working Conditions
</b></p><div><ul><li>Indoor, Clinic and Office environment.</li></ul>
<ul><li>Essential physical requirements include sitting, typing, standing, walking.</li></ul>
<ul><li>Lightly active position, occasional lifting of up to 20 pounds.</li></ul>
<ul><li>Reporting to work, as scheduled, is essential.</li></ul>
<ul><li>On site work arrangement.</li></ul></div><br>
<p></p>
<p>
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.</p><p></p><p><br>
Equal Opportunity Employer<br>
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.</p></div>

Clinical Trial Manager

OhioHealth

<p><b>We are more than a health system. We are a belief system.</b> We believe wellness and sickness are both part of a lifelong partnership, and that everyone could use an expert guide. We work hard, care deeply and reach further to help people uncover their own power to be healthy. We inspire hope. We learn, grow, and achieve more - in our careers and in our communities.</p><p></p><p><b>Job Description Summary:</b></p><p></p>The Senior Consultant, Research Data and Technology, will develop and lead specialized technical data and technology activities for systems being used by OhioHealth Research Institute (OHRI) and OhioHealth. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train or lead project team members and colleagues for the effective use of data and technology platforms and applications such as Research Electronic Data Capture tool (REDCap), research use in the Electronic Medical Record (EMR), the enterprise Clinical Trial Management System (CTMS) and/or other databases/applications and also serves as a liaison for Information Technology (IT) and/or Information Security (IS) requests. Under limited supervision, performs responsible and professional work involved in planning, managing, and directing operations for the systems/applications utilized by OHRI and the OH system.<br><br>In addition, this position contributes to the development of new processes, procedures tools, and training to enhance program activities and conducts quality assurance / quality control checks of the work of others. This position serves as a formal and informal leader of multidisciplinary teams establishing and maintaining communications with Investigator, project teams, sponsor, and others.<p></p><p><b>Responsibilities And Duties:</b></p><p></p>Serving as the Application / Platform Administrator for the systems (see below) - 40% <br>Reporting, Compliance & Data Integrity Needs - 30% <br>Create and maintain accurate simple and complex reports, spreadsheets, graphs and presentations, to analyze and report various financial, quality and service information as requested. <br>Audits & systems data clean-up. <br>Troubleshoot and resolve systems data issues <br>Training - 10%: Determine, develop materials and implement training for foundation staff for annual Team retreat, new associates and ongoing training needs. <br>Other duties as assigned - 20% <br><br>Application / Platform Administrator <br>Lead OhioHealth and OHRI associates as well as external collaborators to facilitate effective and compliant use of applications such as REDCap, EPIC, CTMS and/or other databases for research, QI, and/or administrative projects. <br>Oversee and lead the development, implementation, maintenance and documentation of software systems or applications, vendor-supplied programs, programs with users and vendors. <br>Collaborate with developers and end-users to ensure that application functionality meets client needs. Test solutions, problem-solve issues and coordinate enhancements. Gather business requirements; creating functional specifications; and identifying, documenting and resolving design issues. <br>Oversee team to complete system validation of new releases. <br>Provide oversight of user education on capabilities, limitations, best practices, and compliant procedures for using applications. <br>Provide oversight to maintain application access, use, and training instructions on the OHRI web site and update as appropriate. Supports and analyzes metrics integration and execution for optimal results. Plan and communicate readiness plan. <br>Serve as an escalation point for the most challenging support issues. Contact vendor or external individuals to resolve issues. <br>Oversee the building of studies, databases, survey instruments, data collection tools, and other resources for conducting research, QI, and administrative projects. <br>Employ best practices for data integrity, confidentiality, and HIPAA compliance. <br>Regularly participate and lead external administrator user group activities and meetings. <br>Coordinate with OhioHealth Information Services on server upgrades and issues to ensure data integrity and minimize downtime; and manage database maintenance as directed. <br>Provide technical input on feasibility for projects involving information systems. <br>Recommend initiatives and process improvements to OHRI leadership to meet the needs of OHRI and use resources wisely to achieve maximum results. <br><br>Compliance <br>Manage and oversee security approach and standards for infrastructure and applications. Identify security risks and mitigation approaches, using internal and external sources as appropriate. Manage access to systems including activation and deactivation. <br>Manages testing and quality assurance process. Participate in audit preparedness activities for assigned studies/projects. <br>Responsible for managing documentation and reporting for applications and other technology-based projects to ensure compliance with internal SOPs, GCP guidelines, sponsor guidelines and current applicable regulatory regulations. <br>Lead risk assessments of technology-based research activities. Communicate concerns to OHRI leadership in a timely manner. <br>Comply with hospital, departmental policies, procedures and processes. <p></p><p><b>Minimum Qualifications:</b></p><p></p>Bachelor's Degree: Computer and Information Science<p></p><p><b>Additional Job Description:</b></p><ul><li><p>Degree in computer science or related field, or related or equivalent combination of education, training and work experience in research. Strong verbal and written communication skills.</p></li><li><p>Ability and desire to provide exceptional customer service.</p></li><li><p>Demonstrated problem-solving abilities.</p></li><li><p>Strong computer skills, familiarity with database and information exchange technology.</p></li><li><p>Demonstrated experience working independently using initiative and good judgement with teams.</p></li><li><p>Ability to work effectively as part of a team.</p></li><li><p>Ability to learn complex policies and processes and to implement them independently in daily activities.</p></li><li><p>Applies critical thinking and creative problem-solving skills across a wide variety of software/application systems.</p></li><li><p>Minimum of 3 years of human subjects research experience required.</p></li><li><p>Proven track record of having successfully developed and/or managed at least one database.</p></li><li><p>Thorough knowledge of study design criteria, randomization processes, clinical and biomedical terms used in research studies and scientific and medical concepts and terminology.</p></li><li><p>Thorough knowledge of clinical trial management operations.</p></li><li><p>Thorough knowledge of Federal and institutional confidentiality policies applicable to electronic databases containing protected health information and data collected specifically for research.</p></li><li><p>Demonstrates effective communication (written and verbal), the ability to effectively and accurately exchange, transmit, receive, and interpret ideas, information and needs with colleagues and research team members through appropriate communication methods.</p></li></ul><p></p><p><b><u>SPECIALIZED KNOWLEDGE</u></b></p><ul><li><p>Advanced knowledge of principles of database and applications management.</p></li><li><p>Working knowledge of quality improvement processes.</p></li><li><p>Well-developed organizational skills with attention to details. Documented people skills and professional communication ability.</p></li><li><p>Goal-oriented person who takes initiative, is self-motivated and a creative problem solver.</p></li><li><p>Proficiency in Excel and electronic data capture systems is required. </p></li></ul><p></p><p><b><u>DESIRED ATTRIBUTES</u></b></p><ul><li><p>Master's degree in data management or related field.</p></li><li><p><b>Kind and Length of Experience</b>- 4+ years of clinical research involvement.</p></li></ul><p><br /> </p><p></p><p></p><p><b>Work Shift:</b></p>Day<p></p><p><b>Scheduled Weekly Hours :</b></p>40<p></p><p><b>Department</b></p>Research Business Services<p></p><p></p><p>Join us!<br>  if your passion is to work in a caring environment<br>  if you believe that learning is a life-long process<br>  if you strive for excellence and want to be among the best in the healthcare industry</p><p></p><p>Equal Employment Opportunity</p><p></p><p>OhioHealth is an equal opportunity employer and fully supports and maintains compliance with all state, federal, and local regulations. OhioHealth does not discriminate against associates or applicants because of race, color, genetic information, religion, sex, sexual orientation, gender identity or expression, age, ancestry, national origin, veteran status, military status, pregnancy, disability, marital status, familial status, or other characteristics protected by law. Equal employment is extended to all person in all aspects of the associate-employer relationship including recruitment, hiring, training, promotion, transfer, compensation, discipline, reduction in staff, termination, assignment of benefits, and any other term or condition of employment </p><img src="https://www.jobg8.com/Tracking.aspx?TyfogLXvGD0NSOZQf72%2f5mdyPbab%2bjshv" width="0" height="0" />

Sr. Research Data Technology Consultant - REDCap, CMTS and EPIC

INSIGHTEC

<div><p>Insightec is a growing medical technology company transforming patient lives through innovative incisionless surgery.</p><p></p><p><br>
Our culture is as unique as our people, a diverse global team, with different ideas, skills, interests, and cultural backgrounds driven by our core values &ndash; Our Patients, Integrity, Team, Quality and Innovation.</p><p></p><p><br>
Our dedication to making a real impact on the lives of millions of people and paving the path to a bright future for healthcare, is what bonds us as a Team. We work together in a dynamic collaborative environment to deliver successfully while believing and driving a life-work balance philosophy that encourages our employees to do things that are meaningful outside of work. Every role is significant, your voice is heard, and your ideas are encouraged. We challenge and empower our people to be great at what they do while providing a flexible work environment.</p><p></p><p><br>
Walking through our corridors, you will be inspired by stories of career journeys at Insightec. We take pride in growing internal talent and encourage our employees to achieve their professional ambitions. With employees in Israel - Haifa and K. Ono, Miami and Dallas, Shanghai, Tokyo and Europe, we offer in each region competitive perks and benefits.</p><p></p><p><br>
Do the most meaningful work of your career by joining us on our mission to transform tomorrows, today.</p><p></p><p><br>
The Clinical Project Manager serves as the clinical trial lead and will lead clinical trial initiatives for Insightec. You will ensure trial compliance, regulatory alignment, and operational efficiency while collaborating with cross-functional teams such as Medical Affairs, R&amp;D, and Quality &amp; Regulatory to advance Insightec&rsquo;s clinical pipeline. The Clinical Project Manager is expected to independently manage the clinical trial by effectively planning and executing the study to ensure quality of deliverables within the specified budget and timeframe.</p><p></p><p><b><br>
Key Responsibilities:</b></p><ul><li>
Clinical Trial Management:</li><li>
Lead and manage multiple clinical trials from initiation through to completion, ensuring adherence to study timelines and budgets.</li><li>
Collaborate with investigators, vendors, and cross-functional teams to ensure study execution and operational excellence including implementation of best practices such as quality by design.</li><li>
Oversee the preparation and review of trial-related documentation, including protocols, informed consent forms (ICFs), case report forms (CRFs), and clinical study reports.</li><li>
Support creation of investigator brochures, clinical evaluation reports, publications and other documentation such as annual reports as applicable.</li><li>
In partnership with R&amp;D Program Management, develop and drive cross functional study timelines related to trial setup and execution</li><li>
Other roles/responsibilities will be defined as needed</li></ul><p>
Team Leadership:</p><ul><li>
Drive the cross functional internal study team ensuring appropriate alignment, risk management and coordination across all participating functions.</li><li>
Successfully interface with Data Management, Biostatistics and Clinical Monitors to ensure seamless monitoring and data cleaning initiatives to meet study deliverables and timelines</li><li>
Foster a collaborative team environment focused on operational efficiency and continuous improvement.</li><li>
Regulatory and Compliance Oversight:</li><li>
Ensure that clinical trials are conducted in compliance with all applicable regulations and ISO 14155 and ICH-GCP guidelines as applicable.</li><li>
Lead submissions of clinical trial documents to central IRB/IECs as applicable and ensure insurance and recruitment materials are prepared appropriately.</li><li>
Support the preparation and submission of clinical trial applications, including IDEs, PMAs, 501K, INDs, and other regulatory documents with functional leads from regulatory affairs.</li><li>
Manage interactions with Regulatory Affairs and external vendors to ensure timely submissions and approvals.</li><li>
Budget and Resource Management:</li><li>
Develop and manage clinical trial budgets, ensuring efficient use of resources and timely financial reporting.</li><li>
Monitor and control trial costs to ensure alignment with project forecasts and company objectives.</li><li>
Negotiate contracts and budgets with clinical vendors and investigators.</li><li>
Vendor and Site Management:</li><li>
Oversee the selection and management of clinical research sites and clinical vendors (CROs, laboratories, etc.) and ensure they meet performance expectations.</li><li>
Develop strong relationships with clinical sites and external partners to ensure aggressive site startup, high-quality data collection and trial conduct.</li><li>
Perform risk assessment and management, addressing issues proactively to mitigate operational issues.</li></ul><p></p><p><b><br>
Qualifications:</b></p><ul><li>
Bachelor's or Master's degree in life sciences or a related field.</li><li>
7+ Years of experience as a Clinical Project Manager for Class II/III device studies</li><li>
3+ years of regulatory/clinical trial experience in the medical device industry</li><li>
Demonstrates working knowledge of clinical trial design</li><li>
Minimum of three years of experience developing clinical documents including protocols, informed consent, clinical study reports, and investigator brochures among other documents.</li><li>
Knowledge of financial principles in budgeting, budget negotiation, &amp; contracts management.</li><li>
Demonstrates data management skills, tracking study metrics, and adherence to study protocol</li><li>
Fluent in English with oral presentation and training capabilities</li><li>
Able and willing to travel as needed, up to 30%</li><li>
Expertise in GCP and regulatory requirements.</li><li>
Strong leadership and team management skills.</li></ul></div><p></p>

Clinical Project Manager

Dana-Farber Cancer Institute

<b>Job Ref:</b><br>
46863
<br><br>
<b>Location:</b><br>
450 Brookline Ave, Boston, MA 02215
<br><br>
<b>Category:</b><br>
Clinical Research
<br><br>
<b>Employment Type:</b><br>
Full time
<br><br>
<b>Work Location:</b><br>
<b>Remote:</b> occasional time on campus
<br><br>
Overview
<br><br>
The Clinical Research Project Manager I is responsible for the day-to-day coordination and management of Cutaneous Oncology clinical trial activities, primarily focusing on multi-center, PI-initiated trials. They ensure trial and site startup coordination, train site research staff, handle regulatory submissions, track safety events, and communicate with regulatory authorities. Reporting to disease group managers and/or Clinical Trials Office (CTO) leadership the Clinical Research Project Manager I identifies project plan variances and develops contingency plans to maintain project milestones. They may also oversee operational and training aspects of the EPIC/OnCore application, working closely with faculty, staff, and stakeholders to develop infrastructure, procedures, and tracking systems for project management services. This role requires independent work under general supervision within their disease group or CTO, with a focus on ensuring compliance and efficient trial execution.
<br><br>
This position's work location is fully remote with occasional time on-campus in Boston, MA. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI).
<br><br>
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
<br><br>
Responsibilities
<br><br>
<b>Day-to-Day Project Oversight:</b> Manage the daily operations of assigned clinical trials, ensuring efficient execution and adherence to timelines while maintaining compliance with clinical trial regulations. This involves monitoring budgets, resources, and coordinating with cross-functional teams to meet project milestones.
<br><b>Trial Master File (TMF) Development and Maintenance:</b> Develop and maintain the TMF, ensuring all essential documents are organized, accessible, and compliant with Good Clinical Practice (GCP) standards. Regular updates are conducted to ensure compliance with regulatory standards and institutional policies.
<br><b>Protocol and Consent Form Development:</b> Assist the Principal Investigator (PI) in developing protocols and consent forms for initial applications and amendments, ensuring they meet regulatory requirements and are easily understood by participants. This requires translating complex scientific concepts into clear, concise documents.
<br><b>Clinical Trial Phases Management:</b> Initiate, plan, and oversee the start-up, active, and close-out phases of clinical trials, particularly for PI-initiated and multi-center studies. Coordination with stakeholders, including site staff and external partners, ensures smooth transitions between phases and adherence to timelines.
<br><b>Case Report Form Design and Database Maintenance:</b> Design case report forms based on PI directives and maintains study-related databases, ensuring data integrity and compliance with clinical trial standards. Prepare protocol-related reports and data summaries to support ongoing research activities and decision-making.
<br><b>Administrative Support:</b> Schedule research team meetings and conference calls, facilitate mailings, and perform other project-related administrative tasks to ensure effective communication and coordination among team members and external collaborators.
<br><br>
Qualifications
<br><br>
Bachelor’s degree in a field relevant to clinical research required.
<br>Three (3) years of experience in clinical research or project management, ideally within multi-center oncology trials, with specific experience in managing clinical trial operations.
<br>Experience in an academic institution with a proven track record of success in the clinical research field is preferred, particularly in roles involving clinical trial coordination and management.
<br><br>
<b>KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:</b><br>
Basic understanding of clinical trial processes and regulatory requirements, including Good Clinical Practice (GCP) guidelines.
<br>Familiarity with trial management software and tools, such as EPIC and OnCore, for efficient trial coordination.
<br>Awareness of data management practices and documentation standards, with an emphasis on compliance and accuracy.
<br>Strong organizational and time management skills to handle multiple tasks efficiently, ensuring adherence to clinical trial timelines.
<br>Effective communication skills for interacting with research staff, stakeholders, and regulatory authorities.
<br>Basic problem-solving skills to address project-related issues, with the ability to anticipate and mitigate potential challenges.
<br>Ability to work independently under general supervision, while maintaining compliance with clinical trial protocols.
<br>Capability to learn and adapt to new procedures and technologies, including updates in clinical trial regulations.
<br>Competence in maintaining accurate records and documentation, ensuring compliance with regulatory standards.
<br>Understanding of ethical considerations and patient confidentiality in clinical trials.
<br>Ability to collaborate effectively with cross-functional teams and external partners to support trial objectives.
<br><br>
Pay Transparency Statement
<br><br>
The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate’s relevant experience, skills and qualifications.
<br><br>
For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).
<br><br>
<b>Salary range:</b> $76,911 - $85,295
<br><br>
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
<br><br>
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.
<br><br>
EEOC Poster

Clinical Research Project Manager - Cutaneous

Teva Pharmaceuticals

<div><div><div><div><p>Apply now &raquo;</p>
</div></div><div><div><div><div><div><p>Sr Manager, Competitive Intelligence Global R&amp;D
</p></div></div></div></div><div></div><div><div><div><div><b>Date: </b>Oct 17, 2025
</div></div></div></div><div><div><div><div><b>Location:
</b>Navi Mumbai, India, 400706
</div></div></div></div><div><div><div><div><b>Company: </b>Teva Pharmaceuticals
</div></div></div></div><div><div><div><div><b>Job Id: </b>64422
</div></div></div></div><div><div><div><div><div><div><div><div><b>Who we are</b></div>
</div><div>Together, we&rsquo;re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It&rsquo;s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world&rsquo;s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization&rsquo;s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we&rsquo;re always looking for new ways to continue making a difference, and new people to make a difference with.</div></div><div><div><div><b>
The opportunity</b></div>
</div><div><div>
The Senior Manager of Competitive Intelligence (R&amp;D Focus) plays a critical role in guiding research and development (R&amp;D) strategy by providing deep insights into the competitive landscape with a specific emphasis on emerging therapies and clinical development. This individual will proactively identify and analyze competitor pipelines, clinical trial designs, and emerging scientific trends to inform internal decision-making and maintain a competitive edge in the development of innovative pharmaceuticals. This role requires a strong scientific background, analytical expertise, and the ability to translate complex technical information into strategic intelligence.</div></div></div><div><div><div><b>
How you&rsquo;ll spend your day</b></div>
</div><div><ul><li><b>Develop and implement competitive intelligence strategies for R&amp;D:</b> Define the scope of competitive intelligence activities focused on early-stage drug development, identify key intelligence needs related to competitor pipelines, and establish processes for data collection, analysis, and dissemination within the R&amp;D organization.</li>
<li><b>Monitor competitor R&amp;D pipelines:</b> Continuously track and analyze competitor activities in research and development, including preclinical research, drug candidates, clinical trial initiations, trial designs, endpoints, and results.</li>
<li><b>Analyze clinical trial strategies:</b> Critically evaluate competitor clinical trial designs, patient populations, endpoints, and methodologies to identify potential strengths, weaknesses, and opportunities for differentiation.</li>
<li><b>Identify emerging scientific trends:</b> Monitor scientific literature, conference presentations, and patent filings to stay abreast of the latest advancements in relevant therapeutic areas and identify potential disruptive technologies.</li>
<li><b>Provide actionable insights to R&amp;D teams:</b> Synthesize competitive intelligence data into concise and insightful reports, presentations, and recommendations for R&amp;D leadership and project teams to inform research prioritization, drug development strategies, and clinical trial design.</li>
<li><b>Support strategic R&amp;D decision-making:</b> Contribute to the assessment of new research opportunities, target selection, clinical development plans, and go/no-go decisions by providing timely and relevant competitive intelligence.</li>
<li><b>Develop and maintain competitive intelligence tools and resources:</b> Utilize scientific databases, clinical trial registries, patent databases, and other resources to collect, organize, and analyze competitive information relevant to R&amp;D.</li>
<li><b>Collaborate with cross-functional teams:</b> Work closely with scientists, clinicians, project managers, and other stakeholders within R&amp;D to gather information, share insights, and integrate competitive intelligence into the drug development process.</li>
</ul></div></div><div><div><div><b>Your experience and qualifications</b></div>
</div><div><ul><li>Advanced degree in a life science discipline (Ph.D., PharmD, M.D.) with a strong understanding of drug discovery and development.</li>
<li>3+ years of experience in competitive intelligence, R&amp;D, or a related field within the pharmaceutical or biotech industry.</li>
<li>Deep knowledge of clinical trial design, methodology, and data interpretation.</li>
<li>Familiarity with relevant therapeutic areas and disease mechanisms.</li>
<li>Proven ability to analyze scientific literature, clinical trial data, and patent information.</li>
<li>Excellent written and verbal communication skills, with the ability to effectively communicate scientific and technical information to diverse audiences.</li>
<li>Strong analytical and problem-solving skills.</li>
<li>Ability to work independently and as part of a team in a fast-paced environment.</li>
</ul></div></div><div><div><div><b>Teva&rsquo;s Equal Employment Opportunity Commitment</b></div>
</div><div>Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.</div></div></div>
</div></div></div></div></div><p></p><div><p>Apply now &raquo;</p></div></div></div><div></div>

Sr Manager, Competitive Intelligence Global R&D

Search 10000+ Clinical trial data manager jobs near you this October. New roles added regularly across leading industries. Apply today.