Senior Site Contract Specialist - US - Home based

at  Worldwide Clinical Trials

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.

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.
  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.

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;