Manager, Clinical Data Management
Manager, Clinical Data Management - Morrisville, NC Office-based Who We Are Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of ”Bringing Clinical Trials to Life,” we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro-Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare. Position Overview The Manager, Clinical Data Management is responsible for oversight of the Clinical Data Management functions. S/he provides Clinical Data Management strategic oversight for assigned Sponsors; participates in governance meetings and activities, ensuring consistency of Data Management services across trials. S/he participates in business development efforts on behalf of Data Management. Additionally, s/he is responsible for setting standards, process improvement and process workflows, and participating in technology improvement/implementation efforts. Specific tasks would include:
- Accountability for DM team training, mentoring, and career paths
- Acts as an escalation path for internal teams in relation to the Data Management challenges or issues
- Responsible for strategic oversight of assigned sponsors
- Participating in business development activities, including: proposal & budget reviews, bid defenses
- Executive reporting for DM activities
- Responsibility for departmental resourcing, ensuring the right work assignments across teams
- Works with lead team members and project managers with project-level scope management as appropriate
- Writes/reviews/updates Clinical Data Management related Standard Operating Procedures (SOPs)
- May contribute to the annual budget process; performs data gathering and provides input to spending/anticipated spending, at the department level
- Supervisory responsibilities include but are not limited to providing technical and operational guidance and direction, checking output of work, ensuring deliverables are met, and administering company policies including pay programs and performance management
- Bachelor’s degree in a related field of study and 6+ years Clinical Data Management experience or equivalent combination of education and experience and the demonstrated ability to manage results in terms of costs and/or methods and employees effectively.
- Completion of a Clinical Trials certification is an asset.
- Comprehensive understanding of relevant company practices.
- Proficiency with Microsoft Office: Word, Excel, Outlook, PowerPoint.
- Effective verbal and writing skills; English + local language, if relevant.