Key Responsibilities
- Lead clinical studies involving healthy volunteers and patient populations , ensuring effective organization and prioritization of tasks.
- Own and be accountable for all Data Management (DM) deliverables , providing guidance to the DM team to maintain high-quality standards.
- Ensure adherence to protocols , global SOPs , and Good Clinical Practice (GCP) standards across projects.
- Collaborate with Project Managers to define study timelines and maintain communication with cross-functional leads throughout the project lifecycle.
- Provide leadership to DM project teams, coordinating internal meetings and collaborating with EDC Design , SAS Programming , and Statistics teams.
- Monitor project risks, develop mitigation strategies , and use data-driven insights to meet database lock timelines .
- Keep stakeholders informed on budget status , scope changes , and timeline impacts .
- Build and maintain strong client relationships , incorporating feedback from client satisfaction surveys to enhance service quality.
- Track and document scope changes , ensuring appropriate approvals are obtained.
- Mentor and coach internal teams on DM processes, best practices, and continuous improvement.
- Support DM managers in team performance evaluations and provide constructive feedback .
- Stay current with emerging DM technologies and industry trends to drive innovation.
- Maintain accurate records of all data management work and reconcile clinical databases with safety and lab data .
- Represent DM and Biometrics in business development activities , including audits and sponsor meetings.
- Promote Biometrics services to sponsors and perform additional responsibilities as needed.
Qualifications
Education
University / college degree required; equivalent relevant experience may be considered in lieu of formal education.Experience
6–8 years of v experience , with at least 1 year of direct sponsor / client management .Experience in scope management , budget tracking , and handling client concerns is preferred.Strong understanding of the clinical trial process , including DM, clinical operations, and biometrics.Proven ability to meet project timelines with excellent time management and organizational skills .Strong interpersonal and communication skills; ability to work collaboratively in a team environment .Familiarity with medical terminology .Skills Required
Data Management, Scope Management, Budget Tracking, clinical operations