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Clinical Data Management Lead
RTP, NC e US
Job Description
Position Summary
Clinical Data Management Lead (CDM) will work collaboratively in a fast-paced, cross functional team environment. We are seeking a highly motivated individual to join our dynamic Data Management department. This individual will play a key role in ensuring accurate, high quality clinical trial data. Overall responsibilities will include supporting clinical data management activities from study start-up through study closure in support of trial objectives and corporate goals.
Responsibilities
- Serves as the Data Management Lead on various clinical studies.
- Provides vendor DM oversight and management as needed.
- Ensures that data quality and integrity are maintained from study start through database lock.
- Reviews study protocols and assists in the planning and implementation of the data management portions.
- Leads the design of CRFs/eCRF for sound and thorough data collection through the regulatory approval process.
- Trains other personnel on eCRFs and EDC, as needed.
- Authors and maintains data management documents including Data Management Plans, Data Transfer Plans, and Data Review Plans.
- Lead data review, query management, and data management metrics reporting to ensure completeness, correctness, and consistency.
- Serves as an active member of Clinical Study Teams (CST).
- Works with other functions to develop timelines and ensure DM deadlines are met.
- Works with vendors such as central laboratories in support of timelines and data-related deliverables.
- Ensures laboratory data, if applicable, and associated lab normal ranges are reviewed and reconciled.
- Defines eCRF and edit check specifications as necessary to support data collection and analyses required by the protocol.
- Works closely with database builders during programming of EDC databases, edit checks and reports.
- Drives and performs User Acceptance Testing (UAT) activities for clinical trial database build and modifications.
- Develops study-specific eCRF Completion Guidelines.
- Creates and follows study-specific Data Management Plans.
- Creates and maintains data management documentation.
- Ensures data cleaning activities as specified in the Data Validation Specifications and Data Management Plan.
- Works with the appropriate coding group to ensure medical terminology coding is applied to assigned clinical studies.
- Helps support the implementation of data analytics in support of clinical and medical review of data. Assists in training assigned data reviewers in data review.
- Coordinates with cross-functional team members on serious adverse event reconciliation.
- May participate in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities.
- Maintains eTMF for DM documentation and perform archiving of the study database and study documentation.
- Other duties as assigned.
Key Qualifications
- Bachelor’s degree in a scientific subject area preferred
- Minimum 8 years of clinical data management experience in biotechnology or pharmaceutical industry
- Minimum 6 years of Electronic Data Capture (EDC) experience
- Trialmaster EDC Platform
- Proficient computer skills, including Microsoft Office applications
- Must have strong knowledge of Data Management processes and systems
- Solid understanding of clinical drug development processes required
- Must have demonstrated problem solving abilities in a team environment and strong organizational skills and the ability to work in a fast-paced environment
- Proficient in cross collaboration with other functions such as Biostatistics, Statistical Programming, Pharmacovigilance and Clinical Operations
- Excellent written and verbal communication skills are required
- Experience and understanding of ICH, GCP and CDASH/CDISC are required
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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