Senior Outsourcing Manager
Proclinical is currently recruiting for a Senior Outsourcing Manager for a biopharmaceutical company located in Cambridge, MA. Successful candidate will be responsible for all aspects of research and development contracting and vendor management. Provide functional guidance and keep internal and external team aware of all contract status or pending issues.
- Accountable for the management of clinical trial outsourcing details including RFI, RFP, Work Orders, Changes in Scope, negotiations and approvals.
- Responsible for implementing tools and templates for the maintenance of a consistent outsourcing and contracting process across studies.
- Responsible for the preparation of sufficiently detailed Request for Proposal documents in cooperation with internal clients including an optimal balance between costs, time and quality considerations.
- Lead selection teams in selection processes and provides on-going support to clinical teams during the life of a study.
- Lead Study Handoff Meetings in collaboration with Finance and Legal.
- Facilitate negotiation and preparation of contracts, budgets, and related documents, including but not limited to CTAs, change orders, and scopes of work, in support of all research and development activities. Review contracts and budgets for completeness and accuracy and ensure that corrections are appropriately made and documented.
- Facilitate and support contract management tasks with internal and external legal, finance, as well as clinical and other departments.
- Propose alternative contract and/or budget terms acceptable to the Company when vendor / site and Company terms and conditions differ.
- Anticipate risk/benefit issues, assists with remedial action plans, and troubleshoots to resolve any concerns.
- Work with Finance in projecting and tracking trial and project accruals.
- Support the Clinical Operations team in managing provider relationships on a day-to-day basis to ensure high quality service delivery and to address/escalate issues as appropriate.
- Track provider performance and prepare trending analysis to identify and mitigate risk.
- Accountable for maintaining strong relationships with assigned strategic or preferred providers.
- Provide information to Senior Management on vendor performance issues.
Skills and Requirements:
- BA/BS degree in related field or equivalent combination of education and experience.
- 5+ years for Manager level, 7 years for Sr. Manager level in clinical research, contracts, budgets or related experience that includes working in a team-oriented environment.
- Possesses a working knowledge of the regulatory and business risk for all research and development contracts and budgets.
- Ability to work in a fast-paced environment.
- Ability to critically read documents and interpret/draw conclusion from the documents.
- Must have attention to detail and strong negotiation, project management, communication, organizational, documentation, and interpersonal skills.
- Ability to identify risk and propose solutions.
- Strong analytical and strategic thinking.
- Strong skills in Microsoft Office Suite.
- Ability to actively prioritize multiple tasks to meet deadlines in a dynamic environment.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Qas Shafi at (+1) 646-367-2910 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.