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Mgr Sr., Clinical Development
Ref No.: 18-12758
Location: Madison, New Jersey
Position Type:Contract
Start Date / End Date: 09/17/2018 to 03/18/2019
Sunrise System Inc. is currently looking for Clinical Development in Madison, NJ with one of our top client.
Job Title: Clinical Development
Job Id: 18-12758
Location: Madison, NJ 07940
Duration: 6 months
Position Type: Hourly contract Position (W2 only)
 
Position Summary
  • For this position in the Gastroenterology Therapeutic Area, the Senior Manager, Clinical
  • Development may have global or regional responsibilities and fulfil the role of the Clinical Scientist (CS).
  • The Senior Manager, Clinical Development may be asked to participate in internal process
    improvement activities within R&D and Clinical Development, as well as mentor and provide guidance to junior team members.
  • The contractor must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Client policies and procedures. 
Role
  • Clinical Scientist (CS) Oversight:
  • 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 and Clinical Science Lead 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 or external meetings (e.g., with Regulatory Authorities, meetings with external experts). 
Minimum Requirements
  • Relevant science degree (e.g., MD, PharmD, PhD, RN, MS, BS); Scientific knowledge and experience in the relevant Therapeutic Area preferred
  • Minimum 5 years of overall work experience or equivalent combination of experience and education
  • Minimum 4 years of clinical/research experience in the pharmaceutical/device industry preferred
  • Ability to travel up to at least 10% of time, including international travel 
Essential Skills & Abilities
  • The below listed skill sets are core competencies for all Clinical Development positions and the
    expectations for each are proportional to both the level of position and project roles that have been assigned
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 in a solution oriented manner
  • 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
  • Ability to make tough decisions quickly 
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 
Contact
Praful Prasanna
Email: Praful.P@sunrisesys.com | Direct: (732) 272 0326
Or
Sourabh Agrawal | Lead - Talent Acquisition
Direct: (732) 272 0301| Email: sourabh@sunrisesys.com