Prabhdeep Singh

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Manager - Clinical Site Lead Job

Date: Mar 4, 2019

Location: Plainsboro, NJ, US

Company: Novo Nordisk

About the Department
The Clinical, Medical and Regulatory (CMR) department at NNI is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the Food and Drug Administration (FDA) to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

The Position
Responsible for the management and development of Clinical Site Lead (CSL) staff in accordance with Good Clinical Practice (GCP), ICH guidelines, federal regulations, and within defined budgeting. Responsible for operational aspects of planning and management of site performance in accordance with departmental productivity expectations. Close collaboration with other managers within NACO and with various functional units of Novo Nordisk Inc. (NNI.) Accountable to ensure operating budget and operating margins are managed in accordance with expectations, including expenses.

Reports to a Director or Associate Director, Trial Management (TM) within North American Clinical Operations (NACO) Accountable for actively participating in multiple internal cross-functional teams locally to ensure the effective delivery of all functional and departmental milestones. Reporting to this position are Clinical Site Leads. External relationships are with clinical investigators, Contract Research Organizations (CROs), and other clinical research vendors as needed to support business objectives for the department and/or function.

Essential Functions
  • Ensures functional operating budget is managed in line with organizational expectations, including expense management
  • Ensures compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals within the assigned staff
  • Ensures that all personnel understand and work towards corporate, department and individual goals and that the measures of those goals are understood and accepted
  • Ensures that all personnel understand the priorities of the business, are focused on those priorities, and that their level of accountability is understood and accepted
  • Responsible for the coaching, development and growth leading directly to improvement of talents of assigned personnel to meet increasing levels of responsibility
  • Accountable for the quality of CSL staff performance and supports the quality of performance across the function
  • Active membership to local management teams
  • Active mentorship of NACO staff to build talent across the department
  • Actively follows and manages the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way, and instills in all staff across NACO
  • Implements and may participate in continuous improvement processes for TM
  • May provide input and support the maintenance of guidelines, training programs, policies and procedures for the functional locally
  • May support and communicate functional, departmental or organizational initiatives
  • May support the identification of training needs within function or assigned personnel, the development of training materials to meet those needs, and provide of training as required to improve core competency and skill set of the department or assigned staff
  • Responsible for the implementation and execution of strategies employed by the staff to meet corporate or local goals or directives
  • Responsible to ensure proactive management and collaboration on functional issues to ensure that risks and mitigation strategies are identified early and communicated effectively to the Director/Associate Director or head of Trial Management as required based on impact at the core business. Providing guidance and oversight to junior staff on communication of such
  • Accountable for all timelines and effective resource deployment. Evaluates and communicates the probability and impact of risks, develops quality and risk management plans for performance and ensures this is integrated into the overall plan for the site management NACO business deliverables plan
  • Accountable for delivery of the productivity metrics within the assigned timeframes and to the expectations of NACO
  • Accountable for the compliance and quality of CATS reporting for direct reports
  • Responsible to ensure that staff are consistently driving and partnering with the project teams to ensure transparency and partnership structure that assures the appropriate updates are provided, that performance is to their expectations and that there clear understanding of expectations as a project team member from the function to ensure to the success of a matrix management structure
  • Responsible to ensure that staff make the mandatory trial entries are made in appropriate IT systems (e.g., IMPACT, ClinTrack, novoDOCs, etc)

Physical Requirements
0-10% overnight travel required

Development of People
Ensure that reporting personnel have 3P forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the Individual Development Plan (IDP) forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

  • A Bachelor’s degree required (in science related discipline preferred)
  • A minimum of 1 year on-site monitoring experience required
  • A minimum of 7 years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting required
  • Analytical, negotiation, meeting management, cross-functional team and leadership skills required as demonstrated from representation at a management level
  • Demonstrated computer skills (MS Office, MS Project, MS PowerPoint)
  • Knowledge of GCP as relates to clinical trial management
  • Prior supervisory, project management, or leadership experience preferred

Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Requisition ID: 59604BR
State/Provinces: Plainsboro
Job Category: Clinical Development

Nearest Major Market: New Jersey

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