Program Manager, Clinical Development - NJ in Madison, NJ at Apex Life Sciences

Date Posted: 2/2/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Madison, NJ
  • Job Type:
    Management
  • Experience:
    Not Specified
  • Date Posted:
    2/2/2018
  • Job ID:
    819335

Job Description


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. 
  • The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all policies and procedures. 

Minimum Requirements:

  • Relevant science degree
  • Scientific knowledge and experience in the relevant Therapeutic Area preferred 
  • At least 6 years of overall work experience 
  • 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 

Essential Skills & Abilities: 
 

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 

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

To Apply for this position please send resume to:

Vickie Dagit, Recruiter

vdagit@apexlifesciences.com 

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.