Contracts Manager

Serve as primary Functional Lead for the development and management of site contract and budget strategy (including but not limited to Grant Plan analysis, comparison analysis to executed trials, assessment of negotiations per country and/or region, fallback positions/percentages) in partnership with internal and external stakeholders. Enforce organizational principles of integrity and compliance. Develop and/or refine current internal site contract and budget-related processes to promote greater efficiency and standardization across clinical trial portfolio. Draft, negotiate and manage clinical trial site contracts (which may include, but is not limited to confidentiality agreements, Letters of Authority, Letters of Indemnification, and clinical trial agreements as required) in partnership with CRO. Work with CRO and internal study team to identify areas of financial risk/opportunity resulting from the site contract strategy to overall Investigator Grant budget. Define risks and be able to communicate those risks to appropriate internal decision-makers for discussion and resolution. Track, analyze and report to management on metrics, milestones, and projections for site contract negotiations. Manage all Sponsor escalations related to site contracts by engaging with various internal clients in accordance with agreed upon Service Level Agreements and timing. Perform administrative tasks specific to site contract management, such as creating files, updating files with ongoing correspondence, managing the contract execution process, and scanning and entering executed contracts into internal contract database. Contracts Manager (CM) MAJOR DUTIES And RESPONSIBILITIES Serve as primary Functional Lead for the development and management of site contract and budget strategy (including but not limited to Grant Plan analysis, comparison analysis to executed trials, assessment of negotiations per country and/or region, fallback positions/percentages) in partnership with internal and external stakeholders. Enforce organizational principles of integrity and compliance. Develop and/or refine current internal site contract and budget-related processes to promote greater efficiency and standardization across clinical trial portfolio. Draft, negotiate and manage clinical trial site contracts (which may include, but is not limited to confidentiality agreements, Letters of Authority, Letters of Indemnification, and clinical trial agreements as required) in partnership with CRO. Work with CRO and internal study team to identify areas of financial risk/opportunity resulting from the site contract strategy to overall Investigator Grant budget. Define risks and be able to communicate those risks to appropriate internal decision-makers for discussion and resolution. Track, analyze and report to management on metrics, milestones, and projections for site contract negotiations. Manage all Sponsor escalations related to site contracts by engaging with various internal clients in accordance with agreed upon Service Level Agreements and timing. Perform administrative tasks specific to site contract management, such as creating files, updating files with ongoing correspondence, managing the contract execution process, and scanning and entering executed contracts into internal contract database. The CM Will Have previous experience in managing CRO outsourced site contracting experience in global site contracting specifically EU and APAC strong communication and organizational skills. strong motivational skills. the ability to perform issue escalation. the flexibility and ability to work with deadlines. a solution-oriented and problem-solving attitude. a solid knowledge and understanding of the current regulatory requirements in a global environment with demonstrated ability to provide solutions. a strong attention to detail while having the ability to set priorities and meet aggressive deadlines. assume accountability for completing multiple competing tasks in a timely manner. the ability to develop partnerships within own team and across functions in a large and complex global organization. the ability to anticipate difficulties and proactively develop solutions to mitigate risks. excellent customer focus, interpersonal, communication and facilitation skills. EDUCATION And KNOWLEDGE REQUIREMENTS a bachelor’s degree in business, healthcare management or related field preferred. (In some cases, an advanced degree may be desirable.) 5+ years’ work experience in a clinical trials site contract management role either for a CRO or Pharmaceutical company. Prior experience and proficiency in utilizing Excel, Grants Manager and/or Grant Plan, and in interpreting financial models and analyses. Experience in developing processes related to site contracting. applying organizational standards when developing requests for proposals, negotiating terms and drafting contracts. the ability to systematically analyze complex problems, draw relevant conclusions and implement appropriate solutions. Strong verbal and written skills, and ability to convey complex information in a way that others can readily follow. excellent negotiating and persuasive skills, both in one-on-one and group situations demonstrated success in facilitating, communicating and implementing improvement initiatives. Ability to travel to one of the Sponsor locations periodically depending upon place of residence. strong partnering and collaboration skills. a thorough knowledge of ICH GCP and applicable regulations. Flexibility to participate in calls in the early morning or late day. Ability to work in a remote environment while participating on a global team. #J-18808-Ljbffr KPS Life