Company: Worldwide Clinical Trials
Job description: Who we areWe’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.Why WorldwideWe believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!What the Site Contract department does at WorldwideSite Contracting is an essential function within any CRO, and our seasoned team spans decades of experience within the industry and possesses robust legal experience as well. The department is responsible for reviewing, analyzing, and drafting clinical research site contracts, investigator contracts and other project-related contracts. Our global team is familiar with the specific laws for the countries and sites we occupy. We negotiate and finalize clinical trial contracts and services contracts with the Worldwide Legal Department, study teams, Sponsors, investigators, and/or clinical sites.What will you do
- Main point of contact for the Project Team and Sponsor, for all Study site contracting activities, during the life of contracting on the Study.
- Serves as a Lead and Subject Matter Expert (SME) on Clinical Trial Agreement processes at the Study level and in accordance with the Contract and Budget Plan (CBP), outlining a strategy for the contract negotiation process and responsibilities.
- Presents sites contract negotiation processes during Alignment / Launch meetings and provides update during internal and external team meetings until finalization of contracting activities.
- Communicates and facilitates site contracting strategies, contract turnaround/execution timelines, and sites contract tracking requirements.
- Accountable for Study level site contracting tracking tools completeness
- Agrees and negotiates Clinical Trial Agreements templates, fall back language and sites budget negotiation parameters with Global Project Lead and Sponsor.
- Supports, supervises, and mentors allocated Site Contracts Specialists, ensuring effective planning, effective communication, on time issues escalation, problem solving and execution.
- Responsible for ensuring the timely delivery of Study site contracting updates to stakeholders
- Recognizes potential problems/areas of concern and formulates contingency plans during the Clinical Trial Agreement development and escalates appropriately.
- Develops and implements mitigation plan to ensure the Clinical Trial Agreement deliverables are met.
- Works closely with the Global Project Lead, Site Activation Manager, Regulatory Affairs Manager and/or other departments/Leads to ensure delivery of fully executed agreements in support of timely Study site activation deliverables to meet departmental goals.
- Maintains a working knowledge of, and ensures compliance with applicable ICHGCP Guidelines, local regulatory requirements, Worldwide SOPs and project specific procedures; maintains and assures quality of work generated.
- Mastery in negotiating complex contract terms with clinical sites and vendors
- Excellent verbal and written communication skills to interact with internal stakeholders, clinical sites, Sponsors, and regulatory authorities, if required.
- In-depth understanding of international and local regulatory requirements for clinical trials (e.g., FDA, EMA, ICH-GCP).
- Ability to explain complex contract terms clearly and concisely
- Leadership skills to guide and support junior contract specialists
- Ability to collaborate effectively with cross-functional teams, including but not limited to legal, finance, data protection and clinical operations.
- Up to 2 years of experience as a Principal Site Contracts Specialist and 2 – 3 years’ experience leading projects or minimum 6 years Site Contract experience in Clinical Research, Pharmaceutical or CRO industry and 2 – 3 years’ experience leading projects
- Bachelor's Degree or equivalent in business administration, finance, science or related field.
- Excellent verbal and written English language skills.
- Proficiency with MS Word, Excel and Outlook
- Knowledge and understanding of ICH and GCP Guidelines, as well as local country legislation in the sphere of clinical trials and local regulatory requirements
- High degree of organizational, analytical, and team management skills.
- Adept knowledge of the biopharmaceutical/CRO industry and applicable local regulatory requirements.
Expected salary:
Location: North Carolina
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