Senior Site Contract Specialist - US - Home based

Requisition Number: 8204

Position Title: Senior Specialist, Site Contracts

External Description:

Who we are

 

Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers. Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.

 

Why Worldwide

 

We 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’s Department does at Worldwide

 

Site Contracts is responsible for developing, reviewing and assisting with the negotiation of Site Agreements with Institutions and Investigators and providing oversight and expertise to all site contracts activities during all stages of a Clinical Trial including the development of investigator grants, Clinical Trial Agreement templates and applicable plans, negotiation of Clinical Trial Agreements and Ancillary agreements, and mitigating site contracting risks. 

 

What you will do

 

• Prepare country contract templates; draft and send Site Agreements or any document associated to sites to begin negotiations; provide contract execution planned timelines and negotiation status; reviewing study budgets and costs pertaining to contract negotiation;
• Review Site Agreements or any document associated for completeness and accuracy; finalize contract and budget with sites;
• Perform quality check of Site Agreements or any document associated before signature process starts; if requested, provide draft/signed contract/budget to EC/CA for submission purpose, where needed;
• Liaising with Worldwide Legal Department, Data Privacy team, study teams, Sponsor, sites, investigators etc.
• Send Fully Executed Site Agreements or any document associated to: site, eTMF, Central Records, payment team, Sponsor, as applicable;
• Negotiate Site Agreements Amendment with sites; create termination letter and send to sites for signature, as applicable; maintain tracking tool for functional activities; prioritizes effectively and responds to urgent requests within internal team or Sponsor;

 

 

What you will bring to the role

• Communicates and facilitates sites contracting strategies, contract turnaround/execution timelines, and sites contract tracking requirements.
• Send Site Agreements or any document associated to Sponsor, when required; send site specific contract and budget to sites to begin negotiations;
• Advises Worldwide Project Management Team and Clinical Operation Team on contractual issues for Site Agreements or any document associated;
• Perform final quality check of Site Agreements or any document associated before signature process starts;

 

 

Your experience

 

• 2 to 4 years of experience as Contract Specialist in Clinical Research Pharmaceutical or CRO industry, and/or 1-2 years' experience leading projects
• Bachelor's Degree or equivalent in business administration, finance, science, or related field.
• Knowledge and understanding of ICH and GCP Guidelines, as well as local country legislation in the sphere of clinical trials and local regulatory requirements.
• Adept knowledge of biopharmaceutical/CRO industry and applicable local regulatory requirements.

 

 

We love knowing that someone is going to have a better life because of the work we do.

 

To view our other roles, check out our careers page at www.worldwide.com/careers! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

 

City:

State:

Employment Type: Regular

Community / Marketing Title: Senior Site Contract Specialist - US - Home based

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong:

CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.