Associate Clinical Data Management Director

About the position

Provide oversight for the execution of data management activities at the program level (for an indication or for multiple studies within an indication) from study start up through to regulatory submission. In collaboration with cross-functional teams, external partners, and support Data Managers, may serve as the lead study data manager for a large, complex trial or multiple, smaller studies. Will support CDM process improvement initiatives. Participate in staff recruitment, onboarding, training, and mentoring.

Responsibilities

• As the main point of contact to Study Team, work collaboratively with cross-functional team members to meet project deliverables with quality and per agreed timelines
• Lead the planning and execution of data management activities on assigned studies
• Ensure all Data Management study documents are developed and archived
• Establish and lead the Data Working Group (DWG) for assigned study
• Develop and maintain Data Management timelines
• Track and manage progress towards data deliverables through effective metrics tracking, analysis, and reporting
• Effectively identify and mitigate risks to Data Management deliverables
• Identify and resolve data handling related issues
• Provide a high level of expertise in data management to support clinical studies
• Provide clear verbal or written information and hands-on support to project team members and to CROs related to eCRF and database design, data quality, and reporting of database / data quality status
• Develop and execute procedures for data quality review and data acceptance prior to data analyses and/or database lock
• Manage data transfers with CROs and third-party data sources, SAE/AE reconciliation and MedDRA /WHO-DD coding
• Support the transfer, locking, and archiving of study databases. Manage scheduling and time constraints across multiple projects
• Prepare recommendations for new or improved processes for data management and data flow
• Work collaboratively with cross-functional stakeholders to ensure project deliverables and timelines are met
• Direct and oversee activities of Data Management staff assigned to studies and tasks within projects
• Perform project level resource management in conjunction with CDM Management
• Lead electronic submission activities for Data Management as appropriate
• Participate in selecting outsourcing partners for assigned studies including input to Request for Proposal (RFP), review proposals, participate in evaluation/audits and capabilities presentations, and review project scope of work documentation
• Provide oversight of vendors providing Data Management services
• Develop and execute study specific training of staff within a project
• Lead or participate in CDM process improvement initiatives
• Promote and be an advocate for CDM internally and externally
• Direct the activities and hold accountable junior data managers and/or data review teams

Requirements

• BS/BA degree in related discipline and a minimum of 11 years of related experience; or MS/MA degree in related discipline and a minimum of 9 years of related experience; or PhD in related discipline and a minimum of 5 years of related experience; or equivalent combination of education and experience
• Typically requires a minimum of 9 years of related experience and/or combination of experience and education/training
• A minimum of 7 years of clinical data management experience in the pharmaceutical industry or clinical trials
• A minimum of 4 years in a project leadership role
• Experience with Electronic Data Capture (EDC) is required and experience with Interactive Voice or Web Response Systems (IVRS/IWRS) is preferred
• Demonstrated experience leading data management teams is preferred

Nice-to-haves

• Knowledge of GCP is essential
• General knowledge of FDA regulations that govern the execution of clinical trials and Electronic Data Capture (EDC) systems required
• Expertise in CDASH/CDISC standards preferred
• Strong analytical and business communication skills
• Excellent verbal and written communication skills and interpersonal skills are required

Benefits

• 401k plan with generous company contributions
• Group medical, dental and vision coverage
• Life and disability insurance
• Flexible spending accounts
• Discretionary annual bonus program
• Opportunity to purchase company stock
• Long-term incentives
• 15 accrued vacation days in their first year
• 17 paid holidays including a company-wide winter shutdown in December
• Up to 10 sick days throughout the calendar year