The role of Clinical Development Associate Director is a pivotal position within our organization, tasked with providing strategic leadership and direction to teams supporting trials in the Clinical Development department. This position enables asset strategy, focuses on results, and emphasizes cross-functional team collaboration to achieve goals and objectives within the broader Clinical Design Delivery Analytics organization.
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Key Responsibilities:
1. Business Planning
* Partner with functional, cross-functional, and team leadership to provide operational input into the feasibility and resource requirements associated with clinical plans.
* Provide strategic direction and leadership to CTPMs to enable them to drive the implementation of the Regional/Global enrollment strategy, accomplish milestones to plan.
* Collaborate with Medical Sourcing, Procurement, CPM, and compound Team Management to provide and enable decisions related to internal/external-sourcing options.
* Work closely with the clinical project manager to ensure planning databases are accurate and up-to-date.
2. Resource Management
* Align resources based upon team prioritization decisions and regional participation in the trial.
* Manage study management personnel workload based on portfolio, global and regional requirements, and expertise level of the individual.
* Facilitate discussions within functional counterparts to manage team priorities and address unplanned demands.
* Recruit, retain, and develop top talent to ensure a high-performing team culture.
3. Trial Management Expertise
* Facilitate problem-solving, shared learning, and decision-making across clinical functions.
* Participate in risk assessments at the clinical plan level and ensure development and implementation of cross-functional risk management plans at the trial level.
* Ensure inspection readiness of respective study team(s).
* Oversee and coach CTPMs in the timely documentation of deviations.
4. Training and Compliance
* Share responsibility with training group to ensure curriculum maps and training programs/courses are maintained appropriately for staff members.
* Evaluate CTPMs capabilities and behaviors, aid in directly coaching or identifies appropriate coaches for consultants, associates, and assistants.
5. Application/Improvement of Processes
* Generate innovative ideas, lead, and/or provide input into new processes and process improvements within the clinical organization.
* Actively support staff to share any new learning opportunities or technologies within or across clinical functions.
* Encourage staff to utilize metrics data to assess the current status of the clinical program.
6. Communication
* Partner with other cross-functional leadership to identify and facilitate resolution of clinical trial operational issues.
* Facilitate high-level discussions with vendors as necessary.
7. Performance Management
* Manage the Performance Management process for staff members by providing input in yearly objectives, reviewing progress, and providing timely feedback.
* Complete salary administration for reporting staff members.