Clinical Contracts Manager in Berkeley Heights, NJ at Apex Life Sciences

Date Posted: 8/11/2018

Job Snapshot

Job Description


Responsibilities: 

  • Perform and manage all activities associated with the development of clinical site contracts from study concept through to final protocol. 
  • Deliver clinical site agreements that protect business interests and compliance with regulations and laws concerning the same. 

Support Global Project Teams during protocol development by: 

  • Develop Strategy and oversight for all activities for the development and execution of site contracts, for Sponsored study including contribution to Site selection process and site prioritization activities. 
  • Collaborate with key stakeholders on best practice best practice based on compound alignment and cycle time intelligence. 

Take a lead role within the Global Study Teams through: 

  • Prepare, distribute, negotiate, and drive to execution site contracts (MCSAs, CSAs, CRADAs, Appendices, etc.) with the appointed CRO or affiliate as appropriate. 
  • Conduct training and support to appointed CRO and align process and understanding and accountability for deliverables. 
  • Conduct project management for all site contract activities with CRO partners by tracking and measuring project and team timelines and progress through collection of cycle time metrics and other study specific quality; including but not limited to Key Performance Indicators (KPIs). 
  • Working with PRSM outsourcing colleagues on SOW creations for Site contracts. 
  • Communicates metrics, KPIs, and other relevant project information to team and departmental leadership. 
  • Use metrics with CRO’s to identify, manage milestones and risks and appropriate escalation. 

Oversee an outsourced activity for clinical site contracts: 

  • Ensure an Oversight Plan is in place for each sponsored protocol, including an escalation plan per study, propose where appropriate, solutions to issues that may arise during a project or contract life cycle. 
  • Ensures status reports are provided to appropriate parties on a regular basis. Facilitation of contract workflow and communication by the site contracts group both internally and externally. 
  • Aligned to and aware of strategy for the compound and actively participate in higher level discussions about overall company goals, departmental objectives, and specific project aims. 
  • Escalate issues to senior management in timely fashion. 

Working with peers and stakeholders: 

  • Evaluate changes requested within contracts, identify business and/or legal risk associated with such changes and escalate relevant requests to either legal and/or business partners and/or line managers as appropriate. 
  • In conjunction with Grant Lead ensures that clinical contracts are negotiated within the Fair Market Value in accordance to guidelines and SOPs. 
  • Escalate issues when needed and encourage resolution at the lowest appropriate level. 
  • Identify new and best practices for continuous improvement. 
  • Member of cross-functional teams; contribute in meetings as appropriate and influence line function change. 
  • Comply with audit requests and support to any inspection actions as requested. 
  • Collaborate with Grant Lead and Outsourcing compound alignment colleague. 

Skills/Knowledge Required: 

  • BA/BS degree or equivalent
  • 2+ years performing clinical contracting and CRO oversight
  • 3+ years in the Pharmaceutical Industry
  • Advanced knowledge of contract terms and conditions (T&C)
  • Advanced knowledge of financial terms, budgets and financial benchmarking
  • Negotiation, analytical, meeting management, cross-functional team and leadership skills required 
  • Knowledge of Good Clinical Practice (GCPs) as relates to clinical trial management required 
  • Knowledge of contracts workflow systems (e.g. Quickbase) is highly desirable 
  • Knowledge in developing/maintaining guidelines, training programs, policies and procedures for the functional area 
  • Advanced problem solving skills in a team environment 
  • Demonstrated computer skills (MS Office, MS Project, PowerPoint) 

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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.

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.