The Sr. Director of Clinical Data Management is responsible for developing the strategy and execution plans for Clinical Data Management (CDM) that is aligned with the Clinical Data Management Leadership Team’s vision and principles to meet the goals of the Data Science and Systems’ strategies for the assigned project or therapeutic area within CDM. The Sr. Director will establish asset level strategies and tactics to ensure consistency, efficiency, and excellence in the application of standards, establishment of advanced, predictive data monitoring practices from database activation through database release and submission, and knowledge sharing. Drive a culture of delivering to established milestones with the highest degree of stakeholder satisfaction, emphasizing communication and transparency of operations. The role reports to VP, Clinical Operations Oncology.
Key Responsibilities
- Senior leader with accountability for the delivery of high-quality Clinical Data Management (CDM).
- Line manager of CDM staff and/or manager-of-manager of CDM staff, accountable for the recruitment, development, and succession planning of staff. Must be able and willing to be hands-on for study-level deliverables and provide training to staff as appropriate.
- An executive with overall responsibility for meeting the strategic aims, business case, and annual goals/objectives for both internal and external relationships for Clinical Data Management (CDM).
- Focuses on external alliance relationships via the governance bodies for strategic alliances where appropriate.
- Help drives and champion the Clinical Data Management Leadership Team strategy for Clinical Data Management (CDM) and collaborates with others across Ramp;D to drive new holistic strategies across domain areas (e.g. Risk Based Monitoring, etc.).
- Leads significant levels of business change, within own organization and across the broader organization. This will involve implementing and developing ground-breaking ways of working, to ensure we get the best value and standards of delivery through our people and external service providers.
- The role will require regular contact with persons of influence and in decision-making positions within Ramp;D. The Sr. Director of Clinical Data Management requires a high level of cultural sensitivities, empathy, emotional intelligence, and proactive communication expertise. This necessitates considerable tact, discretion and influence to obtain desired outcomes while maintaining ongoing professional relationships.
Requirements
Knowledge, Skills and Experience
- A minimum of a bachelor’s degree in clinical, biological, mathematical sciences or related field, or nursing qualification is required. An advanced degree is preferred. Equivalent experience may be accepted.
- A minimum 12 years of related pharmaceutical development experience with at least 6 years managing CROs is required. Must be able to demonstrate extensive experience in the design of clinical studies. A minimum of 6 years previous management experience is preferred.
- Proven ability to lead teams and strategic functional initiatives and change management activities.
- Extensive experience from within the pharmaceutical industry or clinical research organizations working with clinical data and clinical development processes at every phase of development.
- Extensive knowledge of clinical and pharmaceutical drug development process at various phases of development.
- Solid understanding of US and Global regulations and guidelines (e.g. FDA, EMA, ICH) applicable to clinical development; prior success in partnering with regulatory peers to support timeline and quality regulatory submissions.
- Expert understanding of clinical data management activities, including regulatory standards, tools, and processes to support clinical data management deliverables.
- Proven leadership, planning and execution, initiative, reliability and accountability, quality of work, problem solving amp; decision making, teamwork and attitude, and communication.
- Proven change management ability and track record.
- Extensive experience in working successfully with internal and external partners.
- Ability to apply strategic direction to teams or projects and to gracefully manage through unexpected events and competing priorities.
- Demonstrated excellent written and verbal communication skills, negotiation, collaboration, conflict management and interpersonal skills.
- Proven track record of translating senior level clinical research/scientific business requirements into operational strategies.
- Strong strategic planning and decision-making skills.
- Strong knowledge of Oncology clinical trials
- Excellent verbal, written, analytical, and presentation communication skill