Clinical Contract Manager
Proclinical is currently recruiting for a Clinical Contract Manager with a pharmaceutical company located in Collegeville, PA.
- Tracks status of 50-100+ pending contracts and identifies outstanding issues in agreements
- Manages communication with third parties and internal teams regarding status of contracts
- Responsible for managing timelines and deliverables, and providing regular updates as required by internal stakeholders
- Interacts broadly with internal departments and external parties including clinical operations/clinical scientists, physicians, sites, and vendors
- Works with study delivery leads and CROs/vendors to negotiate contract terms and conditions using fall back language and in collaboration with the legal department, functional teams, and sites. Ensures agreements are clear, comprehensive,
and complete and that (if needed) purchase orders are submitted, tracked, and updated in a timely fashion
- Works with study delivery leads to identify business issues in negotiations and coordinates with relevant stakeholders to obtain necessary information
- Ensures all contract processes and procedures are followed
- Works to build relationships with internal and external parties to encourage collaboration and efficiency in negotiation process.
- Uses judgment to actively address or escalate (per quality standards) issues as they arise and ensure timely execution of agreements
- If/when applicable, ensures that assigned trials and associated spend are entered into the purchase order system and documents stored in appropriate achieve system.
- Proactively liaises with functional groups to determine and define the scope of contract services required as well as identify and facilitate resolution of all business and legal issues (escalating to team and Legal when necessary) to minimize risk to
- Follows all applicable SOPs/POLs/GUIs, HCP, ICH and regulatory guidelines
- Ensures timely and accurate updating of all department databases
- Delivers productive relationships with all clients in order to add value to clinical trials
- Where required, ensures that externally performed study data and records are appropriately and accurately maintained
- Where required, review relevant clinical protocol sections and supporting documentation
- Develop and negotiate in a timely manner medium-to-high complexity Investigator site contracts and budgets, including Amendments
- Reduce risk by ensuring that policies and procedures are adhered to with regard to appropriate authorization and routing of contracts and ensuring that production, distribution and document management occurs
- Act as the single point of contact for Business Groups to develop an understanding of their needs, to determine and define the scope of contract services required, and to identify, facilitate and resolve all business and legal site contractingissues
- Serve as liaison between company and external parties on investigative site clinical research contractual issues
- Identify and proactively raise issues and concerns in a timely, open and appropriate manner, and develop recommendations for resolution to reduce operational, financial and/or legal risk
- Demonstrate effectiveness in both oral and written communication. Effectively express ideas and incorporate feedback into deliverables to generate quality output
- Provide expert advice to develop detailed specifications, negotiate content and execute contracts and contract amendments that are robust, timely, and add significant opportunity for value generation to the business whileminimizing legal and financial risk during the contract life-cycle
Skills and Requirements:
- Bachelor's degree in Life Sciences, Business or related area, or a combination of equivalent education/work related experience
- Experience within the Pharmaceutical Industry coupled with detailed knowledge and understanding of the clinical development process, Phase I - IV
- A proven track record of at least 2-3 years of experience in developing, executing and managing site/investigator clinical research agreements at a global level
- Experience negotiating legal contract language with minimal support from corporate attorneys as well as site budgets
- An understanding of local laws and regulations governing site contracting in the Americas (NA & LATAM), EU and Asia Pacific regions
- Demonstrable interpersonal skills, with the ability to build relationships at all levels, across many disciplines both internally and externally
- Experience with conducting negotiations, influencing, analyzing, problem solving and facilitating
If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.