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 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. Ensures site contract documentation follows sponsor and ProPharma requirements. Works with internal and external team members to implement solutions for project and/or individual site contract related problems. Establishes strong working relationships with customers, internal project teams and sites. Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
Essential Functions:
Administers all contract management processes from start of document draft, through final document completion, negotiations, agreement, and signatures.
Supports agreement on country template contract and budget. Assists in producing site-specific contracts from country template as appropriate.
Leads negotiations of budget and contract with site and with inclusion of cross functional teams as appropriate.
Leads with quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
Leads the reviews of contracts for completeness and accuracy and ensures that corrections are appropriately made and documented.
Assists 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.
Leads with providing and generating (amended) contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions.
Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time.
Collaborates with internal and external legal, finance, and clinical operations departments including communicating and explaining legal and budgetary issues for contract management tasks and issues.
Facilitates the execution of contracts by company signatories.
Supports the development and maintenance of contract templates and site-specific files as appropriate.
Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary.
Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
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 2-4 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.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving the pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio... Read More
