Sr Sites Contracts & Budget Specialist

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

The Senior Clinical Contract and Budget Specialist position is responsible for administering and negotiating site contracts that support clinical trial set up and execution on a global level. This role will ensure site contract documentation follows sponsor and ProPharma requirements, will work with internal and external team members to implement solutions for project and / or individual site contract related problems, establish strong working relationships with customers, internal project teams and sites, and ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/ Sponsor requirements.

Essential Functions:

• Administer all contract management processes from start of document draft, through final document completion, negotiations, agreement, and signatures.

• Support agreement on country template contract and budget. Assist in producing site-specific contracts from country template as appropriate.

• Lead negotiations of budget and contract with site and with inclusion of cross functional teams as appropriate.

• Lead with quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.

• Lead the reviews of contracts for completeness and accuracy and ensure that corrections are appropriately made and documented.

• Assist cross functional teams with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues as per agreed roles and responsibility matrix.

• Provide and generate (amended) contract and / or budget documents as necessary, prepare contract management documentation for projects, and streamline the contract / proposal or internal processes; initiate and introduce creative ideas and solutions.

• Work within the forecasted country / site contracting timelines, ensure they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time.

• Collaborate with internal and external legal, finance, and clinical operations departments including communicating and explaining legal and budgetary issues for contract management tasks and issues.

• Facilitate the execution of contracts by company signatories.

• Support the development and maintenance of contract templates and site-specific files as appropriate.

• Provide functional guidance and keep internal and external teams aware of all contract statuses or pending issues. Prepare correspondence as necessary.

• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP / Sponsor requirements.

• Develop and review Confidentiality Disclosure Agreements (CDA) per study scope. Liaise and negotiate with sites and clients to fully execute the agreement.

• Develop Clinical Trial Agreement and Budget grid templates as needed per study scope.

• Utilize Grants Manager or equivalent internal systems to generate site budget templates per Fair Market Value parameters.

• Assist the Director, Clinical Operations in developing workflows, Work Instructions, drafting SOPs (as a subject matter expert) for the Clinical Contract and Budget Specialist role.

• Deliver any site-by-site client facing updates on the contract status / amendments during study start up or during the maintenance period.

• Required to join client calls as outlined in the project budget or join any ad hoc calls pertaining to contracts & budgets status if the need is warranted.

• Other duties as assigned.

Necessary Skills and Abilities:

• Ability to understand, explain and communicate contract concepts and put into detailed plans for progressing activities.

• Requires above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills. This includes excellent communication and presentation skills, both written and spoken, with an ability to inform, influence, encourage, and motivate.

• Excellent verbal, written, presentation and communication skills are desired.

• Knowledge of FDA and / or applicable regional regulations, ICH GCP Guidelines, and any other applicable regulatory requirements that govern conduct of clinical trials.

Educational Requirements:

• Bachelor’s Degree or International equivalent.

• Advanced degree / Paralegal and / or Law Degree a plus.

Experience Requirements:

• Minimum 5-8 years’ Experience working with site and budget contracts.

• Experience in working in eTMF, CTMS, EDC, DCT and overall systems that support conduct of clinical trials.