Feasibility Document Specialist

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 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 PSN network, this role has 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 of the job include but are not limited to:

• 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:

Minimum Required:

• 2-year college degree or equivalent combination of education and experience, ideally in law, scientific fields, business administration
• Minimum of 2 year of related experience in contract management and relevant experience in feasibility.
• Combination of qualifications and equivalent relevant experience may be accepted as an alternative.

Other Required:

• Competence and relevant experience in the activities required for the role including feasibility.
• Equivalent contract management experience in a clinical research or similar industry setting
• Ability to communicate both verbally and in writing at the English proficiently (Professional level)
• Established experience in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint)

Preferred:

• Experience in contract research, life science, biotech, or pharmaceutical industry.

Skills:

• Strong organizational skills
• Strong attention to detail and understanding of written agreements.
• Good negotiating and interpersonal skills
• Good oral, written communication skills
• Strong computer skills, specifically with MS Word, Excel, PowerPoint, and with web/data-based platforms

Competencies:

• Executes time-sensitive matters while maintaining accuracy and attention to detail.
• Exhibits high self-motivation and can work and plan independently as well as in a team environment.
• Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates.
• Handles sensitive issues with discretion.
• Works well independently and cooperatively with others to achieve common goals in a virtual environment.
• Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.
• Willingness to work in a matrix environment, work independently and as part of a dynamic team.
• Embraces and embodies the established Precision for Medicine’s Cultural Values as an underlying tenet to drive work behaviors.