Associate Clinical Data Management Director (Biotechnology / Oncology)

Exelixis • Alameda, CA

6d

About The Position

SUMMARY/JOB PURPOSE: Provide oversight for the execution of oncology 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. ESSENTIAL DUTIES AND 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 oversees 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 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 DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

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.
• May require certification in assigned area.
• 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 is also required 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
• Knowledge of GCP is essential.
• General knowledge of FDA regulations that govern the execution of clinical trials and Electronic Data Capture (EDc) systems required
• Has extensive experience in relevant industry/profession and area of specialization.
• Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
• Identifies and implements methods and procedures to achieve results.
• Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing.
• Performs a variety of complicated tasks with a wide degree of creativity and latitude.
• Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
• Has good general knowledge of other related disciplines.
• Applies strong analytical and business communication skills.
• Demonstrated Data Management Project Management skills
• Excellent verbal and written communication skills and interpersonal skills are required.

Nice To Haves

• Experience with Interactive Voice or Web Response Systems (IVRS/IWRS) is preferred.
• Demonstrated experience leading data management teams is preferred
• Expertise in CDASH/CDISC standards preferred.

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 oversees 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 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

Benefits

• comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
• Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 1,001-5,000 employees