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Clinical Project Director I

East Hanover, NJ 07936

Posted: 09/18/2023 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 567810 Is job remote?: No Country: United States

Job Description

Job Purpose As the leader of the cross-functional Clinical Trial Team (CTT), leads planning and management of the assigned clinical trial(s) end-to-end to achieve Global Program Team (GPT), Global Clinical Team (GCT), CTT and GDO-TM objectives. Oversees the conduct of clinical trial(s) including budget and resource allocation within assigned trial(s). Drives operational excellence through process improvement and knowledge sharing across trials. Enables an empowered organization that can navigate in a matrix environment and adjust quickly to business needs. Point of escalation for resolution of trial management operational issues within assigned trial(s).

Major Accountabilities Talent Development 1. Builds best talent and an inspired, curious and empowered culture to foster high performance in a matrix environment. Responsible for overall management of trial management associates working on assigned clinical trial(s) including hiring, training, coaching, capability building, performance management and career development. Assigns study responsibilities to assist in the planning, conduct and reporting of clinical trials. Drives functional excellence in education, implementation and compliance to best practices and shares lessons learned for trial management. 2. Contributes to cross functional activities and functional initiatives, when appropriate. Leader of the Clinical Trial Team 1. Leads and manages the global cross-functional CTT to ensure deliverables are met within the established timelines, budget and quality/compliance standards; accountable for representation at all internal meetings related to the clinical trial; chairs the CTT meetings, participates and reports study progress and issues/resolution plan at the GCT, as extended member of the GCT. 2. Drives CTT to plan and adapt innovative solutions that future-proof our clinical trials. 3. Risk Management: Drives the implementation, maintenance and resolution of clinical trial quality risk management process within the CTT. Ensures escalation of appropriate trial risks and issues to the program level. Provides oversight on quality and compliance for assigned clinical trial(s) in conjunction with relevant line functions. 4. Trial planning, execution and close-out: Creates and/or drives trial level timelines. Leads the CTT development of global clinical trial protocol(s), by translating the approved trial concept sheet(s) into efficient, high quality, executable clinical protocols, and trial related documents. Oversees trial feasibility and facilitates development of global recruitment plan including contingencies in collaboration with Strategic Planning &

Feasibility and Trial Monitoring organizations. Oversees and contributes to the development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data quality plan and trial statistical analysis plan in collaboration with the trial data manager, trial statistician, statistical programmer and Clinical Development Representative(s). Oversees activities including document submission to Health Authority and/or Institutional Review Board/Ethics Committee, drug supply forecast and management, and conducting investigators meeting/training and other trial related training when applicable. Leads development of clinical outsourcing specifications and management of interface with Contract Research Organization. Ensures proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial

Master File documentation. Manages and contributes to the development of Clinical Study Reports; reporting of clinical trial results and internal/external publications, when appropriate. Uses data and digital systems and solutions to enable clinical trial planning, management and decision making, and proactive risk management. 5. Resource Management: Assesses trial resource needs in collaboration with Global Trial Program Head. Accountable for trial level life cycle budget management including forecast and annual cost targets; manager of and accountable for clinical work package; accountable to ensure trial budget is revised when applicable.

Key Performance Indicators 1. Grasps the organizational culture and knows whom to involve to remove barriers. Builds support for ideas among stakeholders, negotiates effectively and makes compromises to arrive at solutions. 2. Exercises respect and diplomacy in difficult interpersonal situations. Uses networking skills and relationships to obtain insights and exchange ideas. 3. Anticipates potential conflicts and problems and takes actions quickly to resolve them. Holds everyone accountable to their commitments and delivers successful outcomes that consider all relevant aspects. 4. Constructively deals with problems that don't have clear outcomes. Monitors own effectiveness to see if change is required and recognizes cues that suggest a change in own behavior is needed. 5. Timely, efficient and quality execution of assigned trials and trial related activities within budget, and in compliance with quality standards. 6. Proactive operational planning with effective contingencies and embed risk management mindset in CTT. 7. Cost effective management of budget and resources with limited unforeseen cost overruns.

Job Dimensions Number of Associates: Direct: 1-5 trial management associates Indirect: matrix management of clinical team

Financial responsibility: Internal budget accountability for direct reports. External budget accountability for multiple clinical trials (annual budget varies depending on the type of trials).

Impact on the organization: Successful completion of trial operational and scientific activities, enabling trial deliverables to be fulfilled according to agreed timelines and budget. Well managed trials resulting in timely delivery of high quality analysis of trial data, enabling strategic decisions within the clinical program. Seen as a credible, ethical and preferred partner by key investigators.

Ideal Background Education: Bachelor degree or equivalent degree is required, with advanced degree preferred. At least one of the degrees in life science/healthcare is preferred. Languages: Fluent English (oral and written) Experience: 5 years of operational and managerial experience in planning, executing, reporting global clinical trials in a pharmaceutical company or a contract research organization. Has guided, trained and/or developed direct reports. OR, has mentored and/or served as an onboarding partner in case of no prior people management experience. Proven ability to work independently in a complex matrix environment (including remote or virtual team environment). Strong project management skills and demonstrated ability to meet timelines. Proficient communication, influencing and negotiating skills. Strong interpersonal, problem solving and conflict resolution skills. Experience in developing effective working relationships with internal and external stakeholders Organizational awareness, including experience working cross-functionally and in global teams. Proven record of managing resources (budget and headcount). Established knowledge of ICH/Good Clinical Practice, clinical trial design and global drug development process. Good knowledge of relevant therapeutic area(s) preferred.

?Pay rate: Min 100/hr - Max 156.13
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