The Investigator Contracts Leads will:
- Develop, negotiate, track and execute North American Clinical Study Agreements with institutions and investigators participating in sponsored clinical trials.
- Work with internal and external partners to develop and oversee global site budget development and issue escalation.
- Work with clinical trial sites and directly negotiate cost, business and contractual terms and conditions with investigators/institutions, making changes to contract templates within the Legal division approved parameters and company SOPs, while also using their professional experience to reach agreement.
- Responsible for the Site Contracting function at the Study Level.
- Develop and ensure compliance with a Study Specific Site Contracting Process.
- Ensure all assigned sites complete their Site Contracts timely and in coordination with the site activation plans of the larger Study Team.
- Ensure all status reporting systems and contract management systems are up to date and accurate.
- Attend Study Team Kick-Off Meetings, Study Start-up Meetings, and other ad-hoc meetings to represent the Site Contracting function and be brief Study stake holders on all matters within area of responsibility.
- Collaborate with Site Contracting Support personnel to ensure all systems are current and all departmental processes are followed. Applies acquired job skills and procedures to complete substantive assignments, projects and tasks of moderate scope and complexity in applicable discipline.
- Develop the trust and confidence of Study Managers, Clinical Study Team Leads, Study Start-up Project Managers, Clinicians, payments professionals, and any other roles that intersect with the Site Contracting Function.
- Remote based but need to work in regular Eastern Time Zones hours
- Effectively manage workload and time to execute site contracts on an expedited basis and in line with company operational goals.
- Communicate continuously with study teams to ensure they have realistic expectations of the contracting process, institutions and contracting environment and provide data and status information to enable enhanced study management.
- Develop relationships with assigned key institutions to maintain contractual, budgetary and professional relationships and manage issue resolution, cycle time reduction and process improvement.
- Use professional experience and judgement to determine which issues can be solved without escalation. If escalation is required, ensure a detailed and thorough explanation of the issues is presented to the reviewing party to enable informed and timely decision making.
- Read and understand Clinical Study protocols and apply their contents to the budget development process.
- Oversee the budget development process performed by contracted service providers to ensure required study team members review and approve the study budget and negotiation parameters.
- Negotiate site budgets to ensure institution costs are within fair market value. Use clinical study cost benchmarking tools, company SOPs, prior site contracts, internal department escalation points, and Study Team member feedback to approve or deny budget requests.
- Responsible for effective relationships and collaboration with other company functions.
Negotiate MCSAs with investigator sites/institutions as appropriate.
- Draft, negotiate, track, and execute contract amendments as necessary.
- Follow departmental processes for contract management systems, activation timeline reporting, file structure, naming conventions, etc.
- Source prior negotiated contracts from company.
- Bachelor's degree is required. Degrees in STEM preferred. Master's degree preferred.
- Minimum 4 years direct site contract and budget negotiation experience in industry sponsored clinical studies.
- Experience creating site budgets using a protocol and cost benchmarking tool strongly preferred.
- Proficiency with Microsoft Office and SharePoint required.
- Experience with Grant Plan, goBalto/Oracle Activate, Ariba Contracts Workbench, and Microsoft Teams strongly preferred.
- Time management skills, organization, communication, and pride in work are essential to success.
- Demonstrated success in working in a highly matrix-based organization.
- Fluency in French or Spanish a plus.
Please submit your resume for consideration. Once submitted, feel free to contact Robyn at 646-688-5784for additional information.
Approx. Duration: 18 months
About Hired By Matrix
Hired by Matrix, Inc. founded in 1986, is a certified Woman-Owned Business Enterprise (WBE) dedicated to providing the highest quality of job opportunities to our candidates and staffing services to our clients. We are a full service staffing firm with experience recruiting and delivering for IT, Accounting & Finance, Administrative & Clerical, Clinical & Scientific, and Marketing disciplines. Our long history in the staffing industry and dedication to excellence are the key differentiators that have fueled our success for over 30 years.
Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days and a 401k option after one year.
Equal Opportunity Employer
*CEO Sharon Olzerowicz serves on the WBENC Board and is a long-standing member of the Forum Governing Group.
We work hard to match our candidates with the right career opportunities. Let us find you a #MatrixMatch so you can reach your career goals!
Connect with us on LinkedIn and see how we can impact your career!
Hired by Matrix Career Center: https://www.hiredbymatrix.com/find-work/open-positions/