Clinical Project Director I

Job Title: Clinical Project Director I

Work Location: East Hanover, NJ 07936

Duration: 6Months

Job Type: Contract

Work Type: Hybrid

:

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

• 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.
• 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.
• Builds best talent and an inspired, curious and empowered culture to foster high performance in a matrix environment.
• Contributes to cross functional activities and functional initiatives, when appropriate.

Leader of the Clinical Trial Team

• Drives CTT to plan and adapt innovative solutions that future-proof our clinical trials.
• 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.

Risk Management:

• Provides oversight on quality and compliance for assigned clinical trial(s) in conjunction with relevant line functions.
• Ensures escalation of appropriate trial risks and issues to the program level.
• Drives the implementation, maintenance and resolution of clinical trial quality risk management process within the CTT.

Trial planning, execution and close-out:

• Manages and contributes to the development of Clinical Study Reports; reporting of clinical trial results and internal/external publications, when appropriate.
• 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.
• Leads development of clinical outsourcing specifications and management of interface with Contract Research Organization.
• Oversees trial feasibility and facilitates development of global recruitment plan including contingencies in collaboration with Strategic Planning & Feasibility and Trial Monitoring organizations.
• Oversees activities including document submission to Health Authority and/or Institutional Review Board/Ethics Committee, drug supply forecast and management, and conducting investigator’s meeting/training and other trial related training when applicable.
• Uses data and digital systems and solutions to enable clinical trial planning, management and decision making, and proactive risk management.
• 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).
• 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.

Resource Management:

• 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.
• Assesses trial resource needs in collaboration with Global Trial Program Head.

Key Performance Indicators

• 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.
• Proactive operational planning with effective contingencies and embed risk management mindset in CTT.
• Cost effective management of budget and resources with limited unforeseen cost overruns.
• Timely, efficient and quality execution of assigned trials and trial related activities within budget, and in compliance with quality standards.
• 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.
• 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.
• Exercises respect and diplomacy in difficult interpersonal situations. Uses networking skills and relationships to obtain insights and exchange ideas.

Job Dimensions

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

Financial responsibility:

• Internal budget accountability for direct reports.
• Client seen as a credible, ethical and preferred partner by key investigators. Ideal Background
• 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.

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:

• An onboarding partner in case of no prior people management experience.
• ≥5 years of operational and managerial experience in planning, executing, reporting
• Established knowledge of ICH/Good Clinical Practice, clinical trial design and global drug development process.
• Has guided, trained and/or developed direc reports. OR, has mentored and/or served as
• Proficient communication, influencing and negotiating skills. Strong interpersonal, problem solving and conflict resolution skills.
• Global clinical trials in a pharmaceutical company or a contract research organization.
• Proven ability to work independently in a complex matrix environment (including remote or virtual team environment).
• Organizational awareness, including experience working cross-functionally and in global teams.
• Experience in developing effective working relationships with internal and external stakeholders
• Proven record of managing resources (budget and headcount).
• Good knowledge of relevant therapeutic area(s) preferred.
• Strong project management skills and demonstrated ability to meet timelines.