Clinical Data Manager

About This Role:
The Data Manager in the Implantable Device Unit will play a crucial role in supporting the planning, oversight, and execution of clinical data management activities for studies. This position will act as the primary internal point of contact for data management operations, coordinating both internal functions and external partners. The responsibilities will include contributing to the development and maintenance of study data management plans, ensuring activities align with protocols, timelines, quality expectations, and regulatory requirements. By generating data listings, reports, and summaries using appropriate programming and data analysis tools, aid study monitoring and internal decision-making. Additionally, the Data Manager will fulfill ad hoc data requests, resolve data issues, and collaborate with cross-functional stakeholders to support data quality and study results interpretation. This position is vital for providing leadership and hands-on support for effective study data oversight and CRO performance.

Responsibilities:

• Oversee CRO data management activities by reviewing deliverables, timelines, and resolving issues to ensure alignment with study requirements.
• Generate clinical data reports, listings, and summaries using programming tools to support study monitoring and decision-making.
• Fulfill internal data requests by preparing ad hoc analyses and targeted outputs for stakeholders across various functions.
• Monitor data quality and database readiness by identifying issues and coordinating needed revisions.
• Partner with cross-functional stakeholders on data-related deliverables and issue resolution.
• Collaborate on study data strategy, data review priorities, and CRO oversight.
• Coordinate data cleaning priorities and query management with external vendors.
• Partner on protocol deviation assessment and documentation quality.
• Support resolution of quality issues affecting compliance or data integrity.
• Provide data outputs and analyses for regulatory submissions and safety reviews.
• Review study progress and operational issues impacting data quality and interpretation.

Qualifications & Experiences:

• Detail-oriented individual with a passion for data management and problem-solving.
• Analytical mindset helps effectively oversee complex data operations and collaborate with diverse teams.
• Thrive in fast-paced environments, balancing multiple priorities and deadlines.
• Communication skills enable you to coordinate effectively with stakeholders and external partners.
• Committed to ensuring data quality and integrity, contributing valuable insights for study success.

Required Skills:

• Bachelor’s degree with at least 5 years of experience in clinical data management or related fields.
• Proficiency in generating data output using SAS, Python, and advanced Excel tools (Power Query and/or similar tools).
• Experience in oversight of CRO data management activities.
• Strong analytical and problem-solving skills.
• Excellent communication and collaboration abilities.

Preferred Skills:

• Advanced degree
• Experience with implantable devices and Class III medical device studies.
• Familiarity with regulatory submissions and protocol amendments.