||Manager/Senior Manager, Clinical Contracts
||Job Code/ Req#:
||Florham Park, NJ
|Mgr / Sr. Mgr
Perform, manage and oversee all activities associated with the development of clinical site contracts from study concept through to final protocol. Deliver clinical site agreements that protect Hutchison business interests and compliance with regulations and laws concerning the same including compliance with Fair Market Value (“FMV”).
Major Responsibilities and Duties
Coordinate and support the Contracts group in US Oncology Clinical Development.
- Independently develop strategy and oversight for all activities for the development and execution of site contracts, for Sponsor sponsored study of any complexity, including contribution to site selection process and site prioritization activities;
- Take on leadership position as the spokesperson for Site Contracts Department in order to help educate internal stakeholders regarding site contracts negotiation strategy and timelines to support data driven decision making
- Supporting as Global Contract Manager, one point of contact for multiple studies
- Prepare, distribute, negotiate, and drive to execution site contracts (MCSAs, CSAs, CRADAs, Appendices, etc.) with the appointed CRO or affiliate or directly with the site as appropriate
- Develop, Negotiate and Execute Clinical Development (CD) contract amendments.
- Aid in the preparation of high-level budgets affecting amendments in partnership with Finance
- Primary contact for internal/external USCD contract inquiries, provide guidance, solutions and triage higher level questions to management team.
- Drive and Manage Amendments by supporting central repository, which streamlines the Amendment process with greater transparency and accurate planning and
- Created a Template which automates e-mail notice for FE Contract/Amendment.
- Participate in projects for developing contract management/outsourcing management infrastructure (e.g. Sharepoint, Access and Excel).
- Work with Site Contracts Department outsourcing colleagues on SOW creations for Site contracts.
- Participate to the elaboration and 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.
- Identify potential risks and manage issue resolution of high complexity.
- Proactively create back-up and or mitigation plans in order to get in front of potential trial specific risks
Qualifications and Education Requirements
- BS/BA or advanced degree or equivalent years of professional experience
- Minimum of 5 years of clinical management experience, inclusive of contracting and negotiation (Pharma contracts management experience)
- Ability to conduct above referenced responsibilities with high level oversight and mid/high-level competency
- Must be able to work independently
- Display strong organizational/project management/interpersonal skills, communication skills.
- Be a performance-oriented individual
- Prior experience with clinical trial/medical process improvements
- Oncology experience with investigator initiated and sponsored trials experience