Sr. Clinical Sciences Project Manager @ Novartis - East Hanover, NJ

Job Overview

4 months ago

Sr. Clinical Sciences Project Manager

Novartis - East Hanover, NJ

7000 patients, 1200 sites, 40 countries, over 100 clinical studies led by our team last year.

Who are we?
We are Clinical Sciences and Innovation at Novartis. A dynamic group of Clinical Scientists who plan and execute early phase trials worldwide. From First-in-Human to Proof-of-Concept and beyond. We design and operationalize trials, ensuring they run smoothly, on time and – most importantly – with patients’ interests to the fore.

As a Sr Clinical Sciences Project Manager (CS PM) you will be accountable for all aspects of the management and clinical execution of early phase clinical trials within Translational Medicine (TM).

In the CS PM role you will lead the planning, oversight and/or implementation of all operational aspects of TM Phase 1 and clinical pharmacology trials from study concept to reporting according to timelines, budget, operational and quality standards (ICH/GCP/Novartis SOPs and procedures).

Your main accountabilities will be to:

  • Act as the Sr Clinical Project Manager/Study Lead for Phase I and clinical pharmacology trials including outsourced trials conducted via the Phase 1 Clinical Pharmacology Partnership (Ph1 CPP) model
  • Be responsible for oversight of all outsourced activities, ensuring CRO partners meet timelines and deliverables aligned to project priorities and strategy, and keeping key internal stakeholders informed.
  • Lead and matrix-manage the multidisciplinary Clinical Trial Teams (Project CTT, Ph1 CP team and support functions) to ensure all trial deliverables are met. Chair team meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards. Communicate study progress to CTT, CS&I Management, TA Heads and project team members.
  • Lead all aspects of study planning and manage study set-up, in collaboration with procurement personnel, CTT members, and local country office representatives.
  • Interact with CRO partners/sites to ensure smooth study set up and study conduct, reviewing site performance, protocol and quality deviations, and maintaining awareness of issues raised.
  • Oversee the authoring of the Clinical Study Protocol, amendments and related documents, Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents. Train and support CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility.
  • Support as needed the project Medical Expert on project documentation e.g. briefing books, responses to Health Authority questions, etc.
  • In collaboration with the Medical Expert and Ph1 CP team, manage the ongoing medical/ scientific review of the clinical trial data, and coordinate the data analysis and interpretation for first interpretable results. Oversee the data review and interactions with internal line functions, CRO partner and third parties to ensure high quality data are transferred in a timely manner.

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum requirements

What you will bring to the role:

A Bachelors or Masters Degree in life sciences required; PharmD; PhD level scientist with life sciences background

Preferred Experience:
  • 6+ years of experience in clinical trial / drug development
  • Solid knowledge of Good Clinical Practice.
  • Track record of successfully managing multiple Phase I or clinical pharmacology trials concurrently.
  • Experience in managing external relationships in a clinical research setting.
  • Office and clinical trial software IT computer literacy.
  • Operational project management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities.
  • Clear written and verbal expression of ideas, and ability to be an active/proactive communicator.
  • Possess a proven track record of successfully interacting with and influencing with a wide range of people, building strong positive relationships.
  • Customer orientation awareness and focus.
  • Ability to work independently and in a team environment, being flexible and adapting in a changing environment.

Division

NIBR

Business Unit

Translational Medicine

Country

USA

Work Location

East Hanover, NJ

Company/Legal Entity

Novartis Pharmaceuticals

Alternative Country 1

Switzerland

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

Shift Work

No

Early Talent

No

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