Associate Director, Clinical Project Management (Titusville, NJ) - (Job Number: 0714959)

Associate Director, Clinical Project Management (Titusville, NJ) - (Job Number: 0714959) Description Under the guidance of the Team Leader, Clinical Operations, the Associate Director, Clinical Project Management is responsible for the development of clinical trial strategies, operational management of Phase IIIB and IV clinical studies and subsequent coordination of study data publication for new and existing Operating Company products. This individual is responsible for the execution of clinical trials in accordance with regulatory, corporate and industry standards. Assists in defining clinical programs/initiatives. Provides input to the project plan and budget. Manages creation of study budget and tracks spending; manages clinical supply forecasts across studies. Implements plan for clinical programs and initiatives. Provides input into publication strategy, may be responsible for entire publication process; directs activities for CSR and NDA/sNDA submissionsDrafts protocols, interfaces with KOLs; oversees creation of CRF to insure accuracy and validity; manages vendors (EDC, IVRS, CRO, etc). Plan investigator and advisory board meetings; oversees investigator site management and resolution of issuesResponsible for vendor assessment, selection, management, issue escalation and problem resolution.The Associate Director must possess sound analytical skills and the ability to make decisions that ensure successful outcomes. Working closely with his/her Supervisor, the Associate Director is responsible for the decisions necessary to ensure the timely initiation and completion of projects. Identifies and solves complex problems; provides guidance to others in resolving simple, moderate, and complex problems. Skilled in influencing, negotiating, and conflict management. Key Global Leadership Profile competencies include an advanced skill set for: results & performance driven, collaboration & teaming, strategic thinking, sense of urgency, prudent risk taking, organization & talent development, intellectual curiosity, big picture orientation and self awareness & adaptability together with essential skills in integrity & Credo based actions.The Associate Director, Clinical Project Management will have significant internal interactions with the Scientific Affairs Center of Excellence, Legal, Finance, IM, BRM, Marketing, J&JPRD (especially Regulatory Affairs and Clinical Research). Frequent external interactions with J&J Operating Companies, CROs, consultants and customers; e.g., KOLs, investigators and alliance partners. The Associate Director may participate as a member of project development teams and product/franchise teams and may participate in departmental/company committees. The Associate Director represents company on internal councils, taskforces, interacts with peers, and sr. management. Interacts with Regulatory Affairs and regulatory agencies (e.g. FDA) and maintains a high level of external customer interaction.Must be able to work in a matrixed team/functional environment and work with remote/vitual teams. A minimum of a Bachelor's Degree (preferably in a biological/health science) is required. A minimum of 7 years relevant experience (combination of industry, project/vendor management) plus at least 5 years of clinical operations trial experience. Graduate degree (MA/MS/MBA) is desirable. PMP or CCRP is preferred. Experience with complex trial design, clinical operations activities including working on international trials, management of multiple vendors, use of technology (e.g., IVRS, EDC) and some experience in clinical program strategy development is required. Expertise in multiple therapeutic areas or in depth knowledge in a single therapeutic area is required. Experience with oral presentations and CRO management are also required. Has complete understanding and applies knowledge of GCP, HCC, government regulatory, and legal implications in trial conduct. Must have experience working in a matrix environment and working with remote/virtual teams. Excellent oral and written communication skills and ability to function with minimal supervision are required. Ability to travel approximately 15% (domestic/international) is required as well as between Raritan NJ and Titusville NJ locations. If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today! Apply Now