Sr Clinical Data Manager

at  Katalyst Healthcares Life Sciences

Responsibilities :

• This position will be part of the cross-functional clinical trial team and be responsible for core deliverables such as clinical database design/setup, data collection, data validation, manual review, and timelines.
• All activities will be performed according to quality standards defined by regulations/standards, ICH-GCP.
• Act as the point of contact for DM activities for multiple trials, provide oversight of data collection and management per regulatory and industry standards.
• Provide oversight of the DM CRO and ensure performance against key indicators; provide DM expertise to trial teams.
• Contributes to the development/review of relevant data management documentation, including but not limited to CRFs, CRF Completion Guidelines, Data Management Plans, Edit Check Specifications, Data Review Plans, Data Cleaning Plans, Data Transfer Specifications, etc.
• Review CRFs to ensure alignment with protocol; lead and perform sponsor acceptance testing of the eCRF; and ensure database structure meets expectations and provide DM insight to promote effective clinical database structure.
• Performs DM lifecycle activities, from study start-up, maintenance, database lock and close-out.
• Provide oversight of the data validation plan and provide DM insight to maximize the data validation strategy.
• Define and perform data quality checks and take action to ensure data quality.
• Provide oversight of key DM documentation and ensure inspection readiness; ensure documentation is aligned with best practices and provide improvement recommendations based on DM expertise.
• Drive and support vendor qualification for data management; define/specify scope of work for functional tasks.
• Participate in development of DM specific SOPs.

Requirements:

• Bachelor’s degree in life sciences, pharmacy, or a related field.
• Minimum of 5 years of industry experience in clinical trial management within the biopharmaceutical industry.
• Very detail-oriented, thorough and organized.
• Demonstrated project management experience with ability to perform under tight timelines and balancing conflicting priorities.
• Versatile communicative and strong interpersonal skills.
• Ability to work effectively in both a team setting and independently.
• Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices.
• Knowledgeable in data privacy requirements for data collection of clinical trial data and information.
• Proficient in Medidata Rave and/or other EDC platform study builds.
• Experience working with and managing CROs/external vendors, 2+ years preferred.
• Experience with writing SOPs, work instructions and guidelines preferred.
• Experience with NDA/BLA activities preferred.
• Experience with regulatory inspection/audit preparation preferred.

• This position will be part of the cross-functional clinical trial team and be responsible for core deliverables such as clinical database design/setup, data collection, data validation, manual review, and timelines.
• All activities will be performed according to quality standards defined by regulations/standards, ICH-GCP.
• Act as the point of contact for DM activities for multiple trials, provide oversight of data collection and management per regulatory and industry standards.
• Provide oversight of the DM CRO and ensure performance against key indicators; provide DM expertise to trial teams.
• Contributes to the development/review of relevant data management documentation, including but not limited to CRFs, CRF Completion Guidelines, Data Management Plans, Edit Check Specifications, Data Review Plans, Data Cleaning Plans, Data Transfer Specifications, etc.
• Review CRFs to ensure alignment with protocol; lead and perform sponsor acceptance testing of the eCRF; and ensure database structure meets expectations and provide DM insight to promote effective clinical database structure.
• Performs DM lifecycle activities, from study start-up, maintenance, database lock and close-out.
• Provide oversight of the data validation plan and provide DM insight to maximize the data validation strategy.
• Define and perform data quality checks and take action to ensure data quality.
• Provide oversight of key DM documentation and ensure inspection readiness; ensure documentation is aligned with best practices and provide improvement recommendations based on DM expertise.
• Drive and support vendor qualification for data management; define/specify scope of work for functional tasks.
• Participate in development of DM specific SOPs