Senior Data Management Lead — Clinical Trials

Novotech

Durham (NC)

On-site

USD 125,000 - 170,000

Full time

27 hours ago

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Benefits offered by this job

Flexible working options

Paid parental leave

Flexible leave entitlements

Wellness programs

Ongoing development programs

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Job summary

Novotech in Durham, NC, seeks a Manager Data Management to lead a Data Management team and ensure trials comply with GCP, regulations and SOPs. You will define resource needs, recruit staff, and coordinate with Biometrics to deliver high-quality data across trials.

Responsibilities include overseeing onboarding, workload management, performance reviews, and budget awareness. Strong collaboration with sponsors and cross-functional teams is essential, with a focus on data quality and process

Qualifications

Degree in clinical, biological or mathematical sciences with minimum 6 years of relevant work experience.
Advanced knowledge of Data Management processes and systems.
Hands-on experience with Medidata Rave, Veeva or Viedoc.
Exposure to RTSM/IWRS and eCOA/ePRO preferred.
Experience with Spotfire, Power BI, JReview and Clinical Data Studio is a plus.

Responsibilities

Manage a team of Data Management staff and ensure line reports meet GCP and SOP requirements.
Define and prioritize resource requirements and allocate across projects.
Recruit and onboard new staff; review workload and development needs.
Provide expert review of Data Management deliverables to customers.
Develop and implement new processes and technology; ensure documentation and validation.
Monitor project milestones and maintain site-level utilization and profitability.
Act as backup for line manager and oversee leave requests and timesheets.
Lead QA through in-progress audits and sponsor audits.