Syneos Health LLC
Site Contracts Specialist with Clinical Trials experience Home-Based in US
USA-NC-Remote · Staff+
Sponsorship not specifiedDetected 51 days ago
Project ManagementBusiness DevelopmentVendor ManagementContract ManagementClinical TrialsPublic HealthFDA RegulatoryResearchCommunicationProblem SolvingAdaptabilityOrganizational SkillsMicrosoft Office
About the role
- Site Contracts Specialist with Clinical Trials experience Home-Based in US Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success.
- Produces site-specific contracts from country template.
- Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
Responsibilities
- Further, nothing contained herein should be construed to create an employment contract.
- We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
- Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
- We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need.
- We are committed to building an inclusive culture - where you can authentically be yourself.
- Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.
- We are continuously building the company we all want to work for and our customers want to work with.
- Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
- May May lead (with supervision) multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
- Provides support to SSUL to agree on country template contract and budget.
Requirements
- Experience in a contract research organization or pharmaceutical industry essential.
- Strong knowledge of the clinical development process and legal and contracting parameters.
- Project management experience in a fast-paced environment.
- Strong organizational skills with proven ability to handle multiple projects excellent communication.
- Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
- BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience. Advanced degree preferred.
- High level of contracts management experience.
- Strong computer skills in Microsoft Office Suite.
- Customer focused and ability to manage challenging priorities and to remain flexible and adaptable in stressful situations.
- Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.
- Good understanding clinical protocols and associated study specifications.
- Excellent understanding of clinical trial start-up processes.
- Good vendor management skills.
- Excellent written/oral communication, presentation, documentation, interpersonal skills as well as strong team-orientation.
- Quality-driven in all managed activities. Strong negotiating skills. Strong problem-solving skills.
Nice to have
- Advanced degree preferred.
Compensation
- The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
- Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
- http://www.syneoshealth.com
- Additional Information
- Tasks, duties, and responsibilities as listed in this job description are not exhaustive.
- The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
Benefits
- Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success.
- 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.
- Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Company info
- The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
- The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.
- The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Visa & Work Authorization
- Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues
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