
Senior Medical Study Lead
1 week ago
As a Senior Clinical Project Manager, you will be responsible for leading clinical studies involving healthy volunteers and patient populations. You will ensure effective organization and prioritization of tasks, as well as own and be accountable for all Data Management (DM) deliverables.
You will provide guidance to the DM team to maintain high-quality standards and ensure adherence to protocols, global SOPs, and Good Clinical Practice (GCP) standards across projects.
Collaboration with Project Managers to define study timelines and maintaining communication with cross-functional leads throughout the project lifecycle is also essential.
Additionally, you will monitor project risks, develop mitigation strategies, and use data-driven insights to meet database lock timelines.
Keep stakeholders informed on scope changes and timeline impacts.
Build and maintain strong client relationships by 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- University/college degree required; equivalent relevant experience may be considered in lieu of formal education.
- 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.
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