clinical data specialist

IQVIA India

<div>
 
 
 Project Role:
 
 Clinical Data Specialist (UAT)
 
 
 
 Work Experience
 
 : 2-5 Years.
 
 
 
 Work location:
 
 Kochi/Kolkata/Bangalore
 
 
 
 Work Mode:
 
 Hybrid
 
 
 
 Must Have Skills:
 
 Clinical data management, Start up, UAT Shift Timings: 5:00 am -2:00 pm / 2:00 pm &ndash; 11:00 pm. The shift assignment is purely based on project requirements and the candidate must be open to working in either of two shifts. FYI: Transportation boundary is 35 KM. no exceptions.
 
 
 
 
 
 
 Job Overview:
 
 
 
 Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager.
 
 
 
 
 
 
 Job Responsibility:
 
 
 
 &bull; Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that don't require extensive programming expertise) with guidance.
 
 
 &bull; May serve in the role of back-up to a DOC or DTL.
 
 
 &bull; May conduct data review.
 
 
 &bull; May write and resolve data clarifications.
 
 
 &bull; May lead database audit team.
 
 
 &bull; May develop and test databases and edit specifications.
 
 
 &bull; May perform testing of programming.
 
 
 &bull; May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team
 
 
 &bull; Interprets the study protocol. Providing knowledge in validation tasks and performing database validation efforts to ensure delivery of high-quality databases.
 
 
 &bull; Accountable for overall quality and delivery of the validation effort.
 
 
 &bull; Develop and test databases and edit specifications.
 
 
 &bull; Meeting objectives as assigned.
 
 
 &bull; Develop and test databases and edit specifications, this includes:
 
 
 &bull; Performs UAT for Edit Checks and Database
 
 
 &bull; Updates the Edit check status appropriately
 
 
 &bull; Communicates issues for erroneous Edit Checks to the programmer within the Data Management Plan
 
 
 &bull; Communicates any documents updates or uncertainties to the Lead Data Manger within the Data.
 
 
 
 
 
 
 Technical Skills:
 
 
 
 &bull; Understand and comply with core operating procedures and working instructions.
 
 
 &bull; Develop and maintain good communications and working relationships with CDM team.
 
 
 &bull; Communicate ideas for process improvement.
 
 
 
 
 
 
 Educational Qualification:
 
 
 
 &bull; Bachelor's Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology Req
 
</div>

Clinical Data Specialist (UAT)

University of Miami

<div><h2 class="jobSectionHeader">Current Employees:
</h2>If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet .
The University of Miami/UHealth Department of SCCC CRS has an exciting opportunity for a Full Time Clinical Research Data Specialist to work at the UHealth campus in Miami, Fl.
CORE JOB SUMMARY
 
The Clinical Research Data Specialist assists in creating, updating, and maintaining research charts and case report forms, including regulatory related issues, in accordance with department standard operating procedures, under the supervision of the Principal Investigator (PI) and supervisor. The Clinical Research Data Specialist is responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to SOPs, and all applicable regulations and guidelines.
 
 
CORE JOB FUNCTIONS
 
1. Extracts clinical data and research data from electronic medical records and other sources and enters this data in the clinical paper-based or electronic data capture system for each assigned study.
 
2. Manages a workload of studies commensurate to level of experience
 
3. Answers data clarifications (i.e., data queries) for each study.
 
4. Schedules and meets with study monitors and assures patient cases are ready for each monitor visit and items are addressed after each monitoring visit.
 
5. Develops source data worksheets specific to each assigned study.
 
6. Assures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit.
 
7. Assures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines.
 
8. Maintains logs (i.e., TAS submissions, Velos etc.) in a timely manner according to department SOPs.
 
9. Participates in site initiation visits (SIV), monitoring visits and participates in site disease group (SDG) team and PI oversight meetings as required.
 
10. Assists multidisciplinary team in research activities.
 
11. Maintains study binders and filings according to protocol requirements and department policy.
 
12. Adheres to all UM and department policies and procedures.
 
13. Compiles patient data for Investigator review to determine patient eligibility for protocol enrollment.
 
14. Maintains screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs.
 
15. Ensures work environment is organized and functions efficiently. Participates in a collaborative, empowered work environment as demonstrated through teamwork. Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center.
 
16. Adheres to University and unit-level policies and procedures and safeguards University assets.
 
 
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
 
 
CORE QUALIFICATIONS
 
Education:
 
High School Diploma or equivalent/relevant experience, certification or license
 
 
Experience:
 
No previous experience required
 
 
Knowledge, Skills and Abilities:
<ul><li>Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
</li><li>Teamwork: Ability to work collaboratively with others and contribute to a team environment.
</li><li>Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
</li>Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders. 
<li>
</li></ul> 
The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.
The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.
Job Status:
Full time
Employee Type:
Staff
Pay Grade:
A6</div>

Clinical Research Data Specialist

Quest Diagnostics

<div>Clinical Trial Study Specialist - Seattle, WA, Monday to Friday, 8:00 AM to 5:00 PM | Hybrid, 3 days onsite a week 
Pay range: $78,450 - $141,200 / year
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. 
Benefits information: 
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:<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>
The Clinical Trial Study Specialist is primarily responsible for coordinating the execution of clinical trial projects including working with the Clinical Trial Study Manager to help manage the scope, timeline and budget of assigned projects.<div>
<div><div><div>Quest Diagnostics honors our service members and encourages veterans to apply. 
 
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. 
 
Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.</div>
</div> 
</div></div><ul><li>Review 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 scope.</li>
<li>Identify risks that may impact our ability to successfully complete the scope of the project in the timeline or budget available and communicate those to the Clinical Trial Study Manager.</li>
<li>Identify new or out of scope requests from customer and communicate with Clinical Trial Study Manager 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>Assist Clinical Trial Study Manager in developing overall project plan and maintain regular touch points to ensure that timelines are being met.</li>
<li>Communicate with customer about discordant samples, shipping and receiving samples</li>
<li>Tracking, storage, and shipping of samples throughout project lifecycle</li>
<li>Act as a backup for the project manager during times of absence, leading client communication and management of Quest team.</li>
<li>Resolve sponsor queries.</li>
<li>Other duties as assigned.</li>
</ul>
Required Work Experience:
<ul>
<li>1-2 years of healthcare experience or equivalent education and experience.</li>
</ul>
Preferred Work Experience:
<ul>
<li>Previous work in GXP environment desired</li>
<li>Previous laboratory experience preferred.</li>
</ul>
Physical and Mental Requirements:
<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>
Knowledge:
<ul>
<li>N/A</li>
</ul>
Skills:
<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>Ability to multitask and prioritize with little assistance from other staff</li>
<li>Knowledge of Microsoft Word, Excel, PowerPoint, and Outlook</li></ul></div>

Clinical Trial Study Specialist

Catalyst Clinical Research

<div>Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.<div><div><div> 
The Clinical Data Coordinator (CDC) is a key member of the Clinical Development Operations, Data Management Team. The Clinical Data Coordinator will provide data management support for all assigned studies. The CDC Prepares, validates, processes, and maintains clinical data in support of submissions to international regulatory agencies or publication of manuscripts. This will be accomplished with through the use of EDC and SAS software.<ul><li> 
 Assists in the development of edit specifications, based on any available global medical standards, therapeutic area standards, and the protocol, used to clean the study.</li></ul><ul><li> Supports the coding schedule defined in the data management plan.</li></ul><ul><li> Performs manual data listing reviews and submits queries as appropriate.</li></ul><ul><li> Assists in determining when each patient has no more data quality issues, based on EDC, coding, and SAS based queries. Also, must coordinate and review medical and statistical queries and certify they are adequately resolved.</li></ul><ul><li> Coordinates the query management system functions.</li></ul><ul><li> Assists in performing final patient reviews and database lock activities.</li></ul><ul><li> Assists in coordinating the processing of scheduled data transfers (PK/PD data, imaging data, laboratory data) from external vendors</li></ul><ul><li> Performs relevant review/reconciliation of 3rd party data.</li></ul><ul><li> Reviews query responses and ensures data quality.</li></ul><ul><li> May draft or update documents for the data management plan.</li></ul><ul><li> May assist with the SAE reconciliation process.</li></ul> 
Education: Bachelor&rsquo;s degree in related discipline and one year of related experience; or high school diploma. 
Required Skills:<ul><li> Proficient with Microsoft Office Suite.</li></ul><ul><li> Excellent written and oral communication skills.</li></ul><ul><li> Strong organizational, problem-solving, and analytical skills.</li></ul><ul><li> Ability to manage priorities and workflow.</li></ul><ul><li> Versatility, flexibility, and a willingness to work within constantly changing priorities.</li></ul><ul><li> Proven ability to handle multiple projects and meet deadlines.</li></ul><ul><li> Strong interpersonal skills.</li></ul><ul><li> Ability to deal effectively with a diversity of individuals at all organizational levels.</li></ul><ul><li> Commitment to excellence and high standards.</li></ul><ul><li> Creative, flexible, and innovative team player.</li></ul><ul><li> Ability to work independently and as a member of various teams and committees.</li></ul><ul><li> Good judgement with the ability to make timely and sound decisions.</li></ul>
. Ability to be discrete with sensitive company information.</div></div></div></div>

Clinical Data Coordinator Trainee

Accenture

Skill required: Clinical Data Services - Clinical eTMF Management 
Designation: Clinical Data Svs Associate 
Qualifications:Bachelor of Pharmacy
 
Years of Experience:1 to 3 years
 
About Accenture 
Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song&mdash; all powered by the world&rsquo;s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com
 
What would you do? You will be aligned with our Life Sciences R&amp;D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance &amp; Regulatory, helping the world&acirc;&euro;&trade;s leading biopharma companies bring their vision to life &acirc;&euro;&ldquo; enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects. Strategies, methods and tools used throughout the lifecycle of the clinical trial regulated content. Includes data review and accuracy checks of trial master file table of contents, head quarters, initial full protocol package and amended FPP checklists, end of trial checklists, essential document reconciliation, and clinical study report appendices. 
What are we looking for? &bull;Adaptable and flexible &bull;Ability to perform under pressure &bull;Problem-solving skills &bull;Detail orientation &bull;Ability to establish strong client relationship
 
Roles and Responsibilities: Document Administrators are responsible for carrying out format check of documents requiring eCTD compliance for New Drug Application/Marketing Authorization Submission. The format check ensures that the technical quality of submission documents in eCTD compliant and meets the document format standards (e.g., PDF property checks, good documentation practice and bookmark/hyperlink checks).
 
Bachelor of Pharmacy

Clinical Data Svs Associate

ICON Strategic Solutions

<div>
 ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
 
 
 We are currently seeking a Clinical Data Coordinator I to join our diverse and dynamic team. As a Clinical Data Coordinator at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
 
 
 
 What You Will Be Doing
 
 
 
 <ul>
 <li>
 Assist Data Management Study Lead in development of eCRF, Data Validation Specifications, and Study Specific Procedures.
 </li>
 <li>
 Review clinical and third-party data based on edit specifications and data review plans.
 </li>
 <li>
 Issue clear, accurate, and concise queries to investigational sites.
 </li>
 <li>
 As required, communicate effectively with peers, clinical data scientist and functional management.
 </li>
 <li>
 Perform other project activities as required in order to ensure that study timelines are met (for example, filing and archiving of study documentation, dispatching of queries to investigator sites for resolution, etc.).
 
 
 </li>
 </ul>
 
 Your profile
 
 
 
 <ul>
 <li>
 Bachelor's degree in a relevant field, such as Life Sciences or Healthcare.
 </li>
 <li>
 Basic knowledge of clinical data management within the pharmaceutical or biotechnology industry.
 </li>
 <li>
 Familiarity with data management software and systems (e.g., Medidata, Oracle RDC, or similar).
 </li>
 <li>
 Strong attention to detail and the ability to work effectively in a fast-paced environment.
 </li>
 <li>
 Excellent communication skills and the ability to collaborate with cross-functional teams.
 </li>
 <li>
 Knowledge of regulatory guidelines and standards (e.g., ICH-GCP) is a plus.
 
 
 </li>
 </ul>
 
 What ICON Can Offer You
 
 
 
 Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
 
 
 In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
 
 
 
 Our Benefits Examples Include
 
 
 
 <ul>
 <li>
 Various annual leave entitlements
 </li>
 <li>
 A range of health insurance offerings to suit you and your family&rsquo;s needs.
 </li>
 <li>
 Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
 </li>
 <li>
 Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family&rsquo;s well-being.
 </li>
 <li>
 Life assurance
 </li>
 <li>
 Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
 
 
 </li>
 </ul>
 Visit our careers site to read more about the benefits ICON offers.
 
 
 At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
 
 
 If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
 
 
 Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.
 
 
 Are you a current ICON Employee? Please click here to apply
 
 
</div>

CDC I

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