Clinical Trials Contracts Specialist
hace 1 día
About the Role
We are seeking a highly skilled Clinical Trials Contracts Specialist to join our team at Syneos Health. As a key member of our Site Contracts team, you will be responsible for administering all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
Key Responsibilities
- Administer all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
- Lead multi-country projects, including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
- Provide support to SSUL to agree on country template contract and budget, and produce site-specific contracts from country template.
- Negotiate budget and contract with site via Site Contracts Service Centre and SSUL, and resolve issues.
- Perform quality control and arrange execution of CTAs, and archive documents into repositories and capture metadata.
- Review contracts for completeness and accuracy, and ensure corrections are made and documented.
- Support business development and represent site contracts/Site Start-Up (SSU) at internal or customer meetings.
- Work with Contract Managers and team members to manage ongoing contract issues, and perform follow-up on outstanding contract issues.
- Generate amended contract and/or budget documents as necessary, prepare contract management documentation for projects, and streamline contract/proposal or internal processes.
Requirements
- BA/BS degree in Business Administration, Public Administration, Public Health, or related field, or equivalent combination of education and experience.
- High level of contracts management experience, preferably in a contract research organization or pharmaceutical industry.
- Strong knowledge of clinical development process and legal and contracting parameters.
- Strong computer skills in Microsoft Office Suite.
- Customer-focused and able to manage challenging priorities and remain flexible and adaptable in stressful situations.
- Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.
- Good understanding of clinical protocols and associated study specifications.
- Excellent understanding of clinical trial start-up processes.
- Project management experience in a fast-paced environment.
- Good vendor management skills.
- Excellent written/oral communication, presentation, documentation, interpersonal skills, and strong team-orientation.
- Strong organizational skills with proven ability to handle multiple projects and excellent communication.
- Quality-driven in all managed activities, with strong negotiating skills and problem-solving skills.
- Ability to mentor, lead, and motivate more junior staff, and provide quality feedback and guidance to peers.
About Syneos Health
At Syneos Health, we are passionate about developing our people, through career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program. We are committed to our Total Self culture, where you can authentically be yourself, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with, because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we're able to create a place where everyone feels like they belong.
Why Join Us
At Syneos Health, we are passionate about developing our people, through career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program. We are committed to our Total Self culture, where you can authentically be yourself, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with, because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we're able to create a place where everyone feels like they belong.
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