I am actively recruiting on an immediate full time SENIOR CLINICAL PROJECT MANAGER position.
The Senior Project Manager will provide support to clinical development operations, trial strategy and project management. All oncology studies (advanced solid tumor,rare cancer/disease)
This individual will facilitate the cross functional preparation, implementation and facilitation of projects related to clinical trials in the US and around the world.
The Senior Project Manager will plan and manage projects or sub-projects under the general direction of the department director.
* The Project Manager will also assist with various project activities, supporting clinical project (phase 1-4 clinical trial programs) initiation, budgeting, planning, execution and completion, which may include clinical project schedules, process development and budgets, tracking, status reporting, project communication, information gathering, coordination and facilitation of meetings, tracking and resolution of issues, and tracking risks and resources and applicable global regulations and ICH/GCP guidelines
* Chair team meetings for assigned projects ensuring goals and deliverables are clearly defined, and issues, decisions, risks and action items are appropriately tracked.
* Provide leadership, guidance, global clinical trial expertise and direction to internal and external project teams to ensure process consistency and knowledge sharing.
* Develop project level budgets and timelines based on project and global business needs.
* Manage vendors/CROs and functional contractors. Lead vendor selection for assigned projects. Oversee vendor management for assigned projects, including negotiation of scope of work, budgets, performance management and issue resolution.
* Assess current and projected demands of a clinical study or program, and partner with department head and leadership to identify and secure resources.
* Analyze and develop action plans for investigational site, vendor and administrative issues.
* In collaboration with the Medical Director, analyze, develop action plans and escalate safety issues, patient care issues, and study design and/or conduct issues.
* Plan, prepare and present at investigator meetings.
* Oversee and contribute to development of key study documents including, but not limited to study protocols, protocol amendments, study plans and procedure manuals, project tools, informed consent forms and clinical study reports. Contribute to development of the compound/project clinical development plan.
* Evaluate, manage and facilitate the timely flow of clinical data to support project objectives.
* Oversee forecasts to maintain sufficient clinical and non-clinical supplies.
* Prepare and present study or project specific updates.
* Represent Project Management & Clinical Operations in partnered development programs.
* Participate in or lead process development initiatives, as required.
- Bachelor's Degree (scientific or medical discipline preferred). Graduate degree is a plus.
- A minimum of at least 9 years of relevant pharmaceutical development experience including at least 5 years of clinical project management in the pharmaceutical industry
- Applied knowledge of FDA regulations and ICH GCP guidelines
- Ability to manage projects and lead study team(s) with minimum supervision, deal with ambiguity, multitask and maintain tight timelines and priorities in a highly professional manner
- Experience in vendor oversight and managing contractors to deliver desired outcomes
- Fluent in MS Project, Excel, PowerPoint and Word tools
- Demonstrated ability to lead a team and to be an adaptable and solution oriented team player
- Experience working with multi-disciplinary cross-cultural teams in a matrix environment
- Experience developing study and program execution strategies and risk mitigation
- Travel Estimate: up to 10%
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