Precision for Medicine is not your typical CRO.
At Precision for Medicine, we have brought together new technologies, expertise, and operational scale to help the life sciences improve the speed, cost, and success rate of bringing life-changing therapies to patients.
What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences.
As our organisation continues to grow, we are hiring a Feasibility Document Specialist to join our team in one of the following countries: UK, Spain, Hungary, Poland, Romania, Serbia, or Slovakia.
This position can be offered fully home-based.
Position Summary:The Feasibility Document Specialist serves as a member of the Feasibility Department at Precision for Medicine.
In support of pre- and post-award feasibility, and in support of growing the PSN network, this role has the responsibility to support reviewing, drafting, negotiating, tracking, and filing of feasibility documents.
The Feasibility Document Specialist supports document management of the Confidentiality Disclosure Agreements (CDA) and Master Confidentiality Disclosure Agreements (Master CDA) for pre- and post-award feasibility and PSN.
The Feasibility Document Specialist works closely with Feasibility, Precision Site Network (PSN), Clinical Operations, Site Start-up, and Contracts study teams to ensure deliverables are in alignment with defined study timelines and Precision Processes and SOPs.
Essential Functions:Collaborate with the feasibility and study teams to develop the CDA template to be used for the pre- and post-award feasibility site outreach.Support the CDA negotiations with the site until final execution.Receive the CDAs signed by the sites, review, route for signature, track, file, and process in accordance with the Precision processes and SOPs.Where required, support reviewing and negotiating CDAs and Master CDA wording with the site and/or the client.Liaise with the Contracts Department to address all legal queries and questions.Work with manager and various internal/external key stakeholders to support resolving/escalating confidentiality agreement contractual issues.Provide regular updates to relevant study team members on the status of confidentiality agreement negotiations and execution.Manage the maintenance of confidentiality agreement files and databases, including archiving.Identify opportunities for process improvement and take corrective actions.Apply processes, templates, and delivery standards for pre-award and standalone feasibility.Assist with document management, coordination tasks, and support for the feasibility department.Qualifications:2-year college degree or equivalent combination of education and experience, ideally in law, scientific fields, or business administration.
Minimum of 2 years of related experience in contract management and relevant experience in feasibility.
#J-18808-Ljbffr