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Program Manager, Clinical Development

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Location
Bedminster, NJ
Hourly
$50.26 - $81.15
Job Type
Contract
Degree
Doctor of Philosophy
Date
Apr 18, 2017
Job ID
2473709
Global Pharmaceutical client needs a 12-24 month contract worker for their Gastroenterology (GI) team.

Minimum Requirements
  • Relevant science degree (e.g., MD, PharmD, PhD); Scientific knowledge and experience in the Gastroenterology preferred
  • At least 4 years of clinical/research experience in the pharmaceutical/device industry
  • Ability to travel up to at least 10% of time, including international travel
  • Authorization to work for any employer in the US (without sponsorship)
Description
The Senior Manager, Clinical Development may have global or regional responsibilities and is expected to fulfil the Clinical Scientist (CS) role within the Gastroenterology Therapeutic Area:
The CS is responsible and accountable for the scientific/clinical implementation of the Clinical Development Plan at the Clinical Trial Team level. The CS supports the Clinical Program Lead (CPL) and Clinical Science Lead (CSL) in the development of the Clinical Development Plan and associated clinical trial content (e.g., protocols, IBs/IDFUs, CRFs, CSRs, regulatory submissions and publications) by contributing to scientific/clinical information aligned with the strategy.
 
The CS is the key Clinical Development contact for the Clinical Trial Team and is responsible for:
•             Representing Clinical Development as a core team member on the Clinical Trial Team
•             Providing a clinical review of study-specific documentation and training materials
•             Performing clinical data reviews
•             Assessing reported protocol deviations
•             Ensuring resolution of identified issues during clinical data and protocol deviation reviews cross-functionally and with Investigational sites in collaboration with the Clinical Trial Team

The CS may present the clinical development aspects of a project and clinical trial results at internal meetings.

Essential Skills & Abilities:
Teamwork:
•             Understands cross-functional roles & responsibilities to effectively & efficiently accomplish team goals
•             Takes initiative to contribute clinically relevant scientific ideas and knowledge to team globally
•             Participates in team activities
•             Actively listens
•             Understands and leverages cross-functional roles and responsibilities
•             Ability to adapt to change in project and team strategy
Influential Communication:
•             Uses facts and data to validate own position
•             Influences through reason
•             Actively seeks to understand other perspectives
•             Articulates business impact
•             Matches communication to audience
•             Ability to build consensus
•             Communicates effectively with internal/external stakeholders
•             Encourages ideas from others
•             Ability to explain complex issues
•             Actively influences others without a direct reporting relationship
Strategic Thinking:
•             Ability to make connections between organization, team, product, ideas, etc.
•             Ability to understand implications of strategic decisions
•             Seeks more knowledge of industry, competitors
•             Welcomes change
•             Encourages innovation and efficiency
Execution and Accountability:
•             Identifies and resolves complex problems
•             Delegates to team and keeps them focused, as applicable
•             Identifies and implements best practices
•             Identifies and drives priorities
•             Takes charge of removing obstacles to project as appropriate with the team
•             Ability to work on and communicate solutions, even in the case of unpopular business needs
•             Meets corporate timelines
Global Mind Set:
•             Demonstrates basic understanding of global pharmaceutical/ device product development environment
•             Builds relationships with global colleagues
•             Demonstrates understanding and respect for cultural differences and needs
•             Inclusive in interaction with others
•             Embraces diversity of thoughts, ideas, and approaches