We have a current opportunity for a Director Clinical Data Management on a permanent basis. The position will be based in Massachusetts. For further information about this position please apply.
Job Title: Director of Clinical Data Management
Location: Massachusetts
Company Overview: We're representing a pioneering biopharmaceutical company dedicated to developing innovative therapies for neurological disorders. Our mission is to improve the lives of patients through cutting-edge research and development.
Position Summary: We are seeking an experienced and highly motivated Director of Clinical Data Management to lead our data management team. The ideal candidate will have a strong background in clinical data management, particularly in the context of neurological clinical trials. This role will be critical in ensuring the integrity, accuracy, and completeness of clinical trial data, supporting our mission to bring new therapies to patients in need.
Key Responsibilities:
- Lead and manage the Clinical Data Management (CDM) team, providing strategic direction and oversight.
- Develop and implement data management plans, including data collection, processing, and quality control procedures.
- Ensure compliance with regulatory requirements and industry standards (e.g., FDA, ICH-GCP).
- Serve as a subject matter expert for various operations, including, but not limited to, electronic data capture, external data standardization, collection, and processing, and the creation of standard data collection forms and associated validation checks and collection processes.
- Collaborate with cross-functional teams, including Clinical Operations, Biostatistics, and Regulatory Affairs, to support clinical trial activities.
- Support vendor UATs for database builds
- Oversee the selection and management of data management vendors and systems.
- Monitor data quality and integrity throughout the clinical trial lifecycle.
- Provide leadership in the development and maintenance of standard operating procedures (SOPs) related to data management.
- Participate in the preparation of clinical study reports and regulatory submissions.
- Stay current with industry trends and advancements in clinical data management technologies and methodologies.
Qualifications:
- Bachelor's degree in a relevant field (e.g., Life Sciences, Computer Science, Data Management); advanced degree preferred.
- Minimum of 10 years of experience in clinical data management, with at least 3 years in a leadership role.
- Experience in neurological or rare disease clinical trials is highly desirable.
- Proficient in clinical data collection/reporting/review and analysis processes using EDC platforms (i.e., Medidata, Veeva, ePRO, etc.) for Phase I-IV clinical trials in pharmaceutical industry
- Strong knowledge of clinical trial processes, regulatory requirements, and data management best practices.
- Proficiency with clinical data management systems (e.g., EDC, CDMS) and software (e.g., SAS, SQL).
- Excellent leadership, communication, and interpersonal skills.
- Knowledge of industry and regulatory standards (FDA and EMEA Regulations, ICH Guidelines, and GCP) including CDISC standards (CDASH/SDTM).
- Ability to work effectively in a fast-paced, collaborative environment.
- Strong problem-solving and analytical skills.
Benefits:
- Competitive salary and benefits package.
- Opportunity to work with a passionate and dedicated team.
- Chance to make a significant impact on the development of therapies for neurological disorders.
- Professional development and growth opportunities.
