Prabhdeep Singh

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Clinical Trial Finance Manager Job

Date: Mar 13, 2019

Location: Plainsboro, NJ, US

Company: Novo Nordisk

About the Department
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk Inc (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
Provides tactical leadership to staff within a department of North American Clinical Operations (NACO). Takes ownership to position & deliver upon near & mid-term NACO goals, including those specifically aligned with the planning & successful delivery of studies within the clinical trial portfolio. Leads & delivers upon improvement/innovation projects for the department and/or as part of a global team and as aligned to a business case, goals &/or future aspirations. Responsible for leading financial oversight across trial portfolios to ensure adherence to the trial strategy and execution to targets. Leads strong and effective communication to global and local stakeholders to ensure consistency. Proactively identifies financial opportunities or risks and partners with internal stakeholders to develop, plan and execute on the opportunity or mitigation. Leads third party contract negotiations with the understanding of the contractual assumptions of the Master Service Agreement (MSA), and accountable for the financial and milestone deliverables. Responsible for the financial reporting, analytics and submission of key financial deliverables; including annual budget (AB), month end, and rolling estimate (RE).

Reports to a Senior Manager (or above) within Clinical Finance & Operations. Manages mutually beneficial relationships with external partners relevant to the design & implementation of clinical trials improvement/innovation projects for NACO & Novo Nordisk (e.g., clinical suppliers/vendors Health Systems, Contract Research Organizations & Site Management Organizations, etc.). Manages relationships positively with multiple internal stakeholders relevant to the design & implementation of clinical trials improvement/innovation projects for NACO & Novo Nordisk (e.g., across NACO, CMR, International Operations (IO), Headquarter (HQ) Research & Development (R&D), & Commercial). Direct/indirect supervisory responsibilities as applicable.

Essential Functions
  • Drives objective setting, prioritization & tracking.
  • Ensures alignment & support is in place to plan & deliver all relevant services/tasks in support of the design, planning & quality* delivery of clinical trials (including required staffing, training & processes).
  • Develops & manages relevant budgets – including compiling, forecasting, tracking & revising.
  • Ability to think strategically and initiate strong and persuasive contractual arguments to support business policies and objectives.
  • Demonstrated analytical skills and critical thinking to resolve issues in a variety of complex situations requiring new solutions.
  • Ability to influence, lead and effectively interface within a matrixed environment and with varying professional levels.
  • Demonstrated commitment to quality, attention to detail and providing the highest quality services to internal and external stakeholders.
  • Demonstrated competencies in the technical, regulatory, and legal terminology of contracts, preferably in clinical trials.
  • Must work with minimal direction.
  • Ability to plan, schedule, and arrange activities in accomplishing objectives.
* Quality, in reference to clinical trial delivery refers to ensuring patient safety, rights & well-being; scientific validity, data integrity & in compliance with all relevant operational & regulatory requirements.

Physical Requirements
Approximately 10-20% overnight travel required (with notice). May on occasion be required to work &/or travel on weekends &/or company holidays.

  • A Bachelor’s degree is required. Advanced degree is preferred
  • A minimum of 7 years’ experience in the design, planning and conduct of GCP clinical trials; with at least 3 of those most recent years working as an employee in clinical, medical and/or regulatory in the pharmaceutical industry (Pharma/Biotech/CRO)
  • Knowledge of ICH-GCP principles and the application of those principles to trial design, planning & conduct of clinical trials preferred
  • Knowledge & direct experience/interactions with the FDA (or equivalent regulatory authority) in relation to the design, planning & conduct of GCP clinical trials preferred
  • Excellent communication skills (verbal, written, presentation) in English
  • Foundational skills in designing and implementing innovation/improvement initiatives, including the required change management
  • A minimum of 3 years’ experience in peer-to-peer coaching/mentoring is required
  • Demonstrated analytical, negotiation and cross-functional team leadership skills
  • Advanced knowledge of MS office
  • Demonstrated strong communication and stakeholder management skills
  • Demonstrated core understanding of clinical operations and budgeting with respects to trial start up through trial closure
  • Strong analytical skills. Capability to turn data into insights and provide recommended actions based on a solid knowledge of the business to Senior Management
  • Ensures contract compliance in accordance with established policies

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: 59520BR
State/Provinces: Plainsboro
Job Category: Clinical Development

Nearest Major Market: New Jersey

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