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Sr. Manager, Site Contracts and Budgets - REMOTE

Employer
Proclinical Staffing
Location
Homeworking
Salary
USD60 - USD104 per hour + Highly Competitive Salary
Start date
17 May 2023
Closing date
16 Jun 2023

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Job Details

Proclinical is seeking a remote Senior Manager, Site Contracts and Budgets for a leading biotech company.

The Senior Manager will collaborate closely with key CDO functional stakeholders, including CSMM, Clinical Trial Excellence and Support (CTES) and Clinical Operations in the development and ongoing oversight of site contracts and budgets execution during the clinical trial start up (SSU) phase to support site activation as per target timelines.

Must be eligible to work in the US.

Job Responsibilities:

  • Responsible for direct oversight and management of site contracts and budgets for multiple assigned clinical trials within designated therapeutic area.
  • Provide consistent site contract/budgets oversight and support to assigned Clinical Operations clinical trial teams, offering up-front and ongoing strategic planning specific to the program and needs of individual studies.
  • Leverage use of internal and CRO provided Investigator Grants (IG) reference data and available Fair Market Value (FMV) benchmarking tools to establish clinical trial-specific IG budget estimates for trial budget forecasting needs.
  • Lead and/or contribute to development of target FMV-based IG budget and negotiation parameters according to therapeutic area (infectious disease, oncology and/or therapeutics) in an outsourced CRO model.
  • Act as lead point of contact (POC) for CRO site contracts and budgets-related activities for assigned studies; oversee the development and approval of global investigator site budgets and associated negotiation parameters. Ensure cross-program/cross-clinical trial consistency in country-level site budget targets and parameters.
  • Responsible for direct management and tracking of CRO investigator site CTA/budget negotiations in alignment with FMV and GCP-driven principles.
  • Collaborate with assigned CRO and Clinical Operations in ensuring that established clinical trial IG budget remains within target during CTA negotiations process
  • Serve as liaison between CRO and Legal/Clinical Contracts and Outsourcing teams in the review and finalization of country-level CTAs/CSA templates.
  • Monitor KPIs, including cycle times and SIV/site activation targets, to ensure adherence to baseline clinical trial timelines for CTA negotiation and site activation.
  • Attend Clinical Trial Team (CTT) and/or joint CRO clinical trial team meetings on an agenda-driven basis, i.e. when strategic decisions that impact site contracts are being discussed
  • Act as lead POC for required site contract and/or budget amendments throughout the duration of assigned studies
  • Proactively identifies site contract-related risks and potential roadblocks.
  • Escalates issues proactively to Sr. Director, CSMM and/or Clinical Operations teams to prevent delays in site activation timelines.

Skills and Requirements:

  • Minimum 5 years' direct experience in global investigator site budget negotiations; preferable experience in CTA template language negotiations and/or support in collaboration with Legal.
  • Effective communication and collaboration with key internal and external stakeholders, including CDO, CRO and investigator site personnel.
  • Familiarity in working within an outsourced model; experience in direct CRO oversight of CTA/budget negotiations.
  • Strong experience in use of various site contract and budget management systems, processes, and computer software (e.g., Grants Manager, Grant Plan)
  • Proficient in MS Office Products with advanced knowledge of Excel; ability to work with and be proficient in stand-alone system applications.
  • High level of attention to detail in management of high volumes of investigator site financial data.
  • Works on increasingly complex and problems of diverse scope requiring critical analysis and comprehensive evaluation of critical factors.
  • Increasingly exercising independent judgment in developing methods and techniques to obtain solutions (and process improvements).
  • Increasing independence in determining specific tasks to accomplish in order to meet certain goals and objectives
  • Increasing self-reliance in performing tasks.
  • Need 3-5 years at a biotech, pharma or CRO
  • Need to have a legal background and be familiar with CTA (Clinical Trial Agreements)
  • Need familiarity with confidential documents
  • CDA & non-disclosure agreements
  • Need experience negotiating outside US -- will be working with CRO's and developing strategies for contracting with sites in EU, UK, Japan, Latin America, Asia etc.

If you are having difficulty in applying or if you have any questions, please contact Kelly Campbell at (+1) 570-277-7115 or k.campbell@proclinical.com.

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.

#LI-KC4

INDCR

Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Company info
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom

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