This role will report to the VP, Biometrics and be accountable for the strategic leadership and functional management of all CDM deliverables in adherence to company SOPs and ICH/GCP., This role manages the CDM function, ensuring the development and readiness of personnel to deliver on existing programs while also being forward-looking and innovative.

Responsibilities

• Provide a high level of expertise and guidance in data management to support clinical studies
• Promote standardization, automation, process improvement and technical enhancement in CDM to improve efficiency
• Lead in the establishment of CDM processes, including identifying, authoring SOPs and Work Instructions to ensure regulatory compliance, GCP, and ICH
• Prepare budget forecast and management of CDM budgets, timelines and resources
• Provide guidance and inputs in the development of key control documents (e.g., data management plans and related documents)
• Lead systematic professional development and provide strong support for direct reports and other members of the CDM department
• Provide leadership and functional mentorship for internal data management staff
• Provide leadership and direction for outsourced activities including quality control and budget
• Oversee all assigned clinical trials to ensure data quality, integrity and timeliness
• Partner closely with the Study Management Team to set study goals and objectives
• Lead and coordinate evaluation, qualification and selection of vendor technology including data visualization tools (i.e. Spotfire), innovative CDM technologies, and advocate data quality
• Conduct budget assessment, contract negotiations, training and oversight for all DM outsourced services from study start-up through study close-out and final reporting
• Responsible for managing and tracking work orders associated with clinical DM activities to ensure that the operating costs for the DM department are achieved within budget.
• Creates and maintains positive, cohesive work environment.

Qualifications

• Bachelor’s Degree with 12 years’ experience in Clinical Data Management at a CRO, biotechnology, or pharmaceutical company; and minimum of 8 years’ prior management experience
• Must have expert knowledge of good data management practices in global clinical trials
• Thorough knowledge of applicable regulatory rules and guidelines
• Complex and/or international trials experience
• Demonstrated proficiency in the data management processes
• Possesses excellent interpersonal communication skills (written and verbal)
• Strong attention to detail
• CDSIC expertise
• Proficient in the use of the clinical data management systems (e.g. Medidata Rave)
• Possesses a positive attitude and works well with others

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.