TITLE: Clinical Project Manager - Princeton, NJ

Job Description
Manages operational and financial aspects of planning and executing clinical trials within projects.

RELATIONSHIPS:

Reports to the Associate Director/Senior Project Manager, Project Management, Clinical Trial Operations (CTO). Receives direction on individual clinical studies by the Senior Project Manager and partners with Clinician responsible for that project. Other internal relationships include other functional groups within CTO, ClinSite, Clinical Operations Support and Outsourcing Group, Project Office, Archiving, Data Management and Statistics. External relationships include other departments in NNI, NNAS, Project Management in HQ and Contract Research Organizations (CROs).

ESSENTIAL FUNCTIONS:

CLINICAL TRIAL MANAGEMENT
· Facilitation of workflow by the various functions.
· Coordinate with Project Associate staff, the ordering, label review, and packaging of drug supplies.
· Management of the detailed site feasibility process. Identification and management of the trending data to identify optimal study sites and provision of ranked site lists to Project Managers and Clinicians as well as identification of potential risks to enrollment based on the trending analysis. Communication of the finding to the Project Manager and Senior Management as required.
· Based on the outcome of the feasibility data provide guidance, training and oversight to the project team, including ClinSite staff, to ensure a comprehensive site selection occurs.
· Generation of the recruitment plan and provision of ongoing assessment of site performance versus original projections as per the feasibility. Active management of any divergence between planned and actual recruitment.
· Cross Trial Team Coordination with the gathering of metrics from all functional groups to identify and manage milestone and risk to project.
· Gathering metrics from all functional areas to identify and manage milestones and risk to project.
· Develops a risk management and mitigation plan and holds each functional group, within the project team, accountable for managing and executing to that plan.
· Monitors trial timelines and resources available.
· Identifies areas where resources or progress are not consistent with project plan to help team and management correct any divergence from time lines.
· Communicates up-to-date information regarding trial progress to all relevant interested parties.
· Trial Team Coordination, motivation and effective leadership locally and internationally.
· Attendance and presentation at Project Review meetings.
· Ability to independent of Senior Management oversight, set-up, lead and complete trials.
· Oversight of protocol and informed consent development
· Oversight of detailed feasibility and site selection.
· Drives performance of external vendors to ensure contracted deliverables are met to budget, time and quality. Provides monthly updates on performance to Senior Management.

BUDGET & CONTRACT COORDINATION
· May work with Outsourcing Group to negotiate contracts with investigational sites and laboratories for content and pricing, ensuring that all regulations and legal requirements are met in coordination with NNAS.
· Facilitates implementation of negotiated changes.
· Provides information for Preparation of trial budgets and in-house agreements.
· Responsible for ensuring project spend is within target % of agreed budget annually.

OUTSOURCING
· Works with the Outsourcing Group to obtain internal agreement of work to be outsourced.
· Ensures adequate and timely performance by (CRO) or Vendor.
· Provides updates on performance to Senior Project Manager and Outsourcing Group.

TEAM COORDINATION
· Facilitates cross departmental work and communications.
· Maintains focus for specific trial activities within departmental priorities.
· Facilitates work within cross-functional teams to assure timely attainment of trial milestones.
· Manages Clinical Team Unit (CTU) meetings at least once a month with representation from Medical, MCT&G, Marketing, Sales, Information Technology and Regulatory. Ensures accuracy of CTU minutes by circulating for review and distribution to members, and NNCI.
· Ensures that the mandatory trial entries are made in IMPACT, EDC administration and updates, ensure CSIM entries and updates are made.
· Active mentorship of junior or new employees to CTO.

TRAINING
· Attend relevant symposia, conferences and scientific meetings, as necessary
· Contribute to training activities in Clinical Trial Operations.

KEY SUCCESS FACTORS:

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
· Bachelors' degree (in science area) or registered nurse, (4 year degree). Advanced degree preferred.
· Minimum of 7 years of clinical trial experience within pharmaceutical and/or healthcare setting, i.e. managing the logistics of clinical trial conduct and developing and executing project plans for clinical development programs.
· International trial management experience preferred.
· Strong preference for hemophilia, inflammation, and/or oncology trial experience. Phase 1-3 only.
· Strong analytical, negotiation, meeting management, cross-functional team and leadership skills required.
· Minimum of 12 months onsite monitoring and site management experience.
· Knowledge of Good Clinical Practice (GCPs) as relates to clinical trial management.
· Demonstrated computer skills (MS Office, MS Project, PowerPoint).

OTHER:
· Works within Novo Nordisk's established policies and procedures and ensures alignment of their work to Novo Nordisk fundamentals.
· Embraces Novo Nordisk Values in spirit and actions.
· Approximately 20-40% overnight travel