Our client is a global healthcare leader based in Cork, Ireland. Their goal is to make a difference for people around the world by discovering, developing and delivering medicines that help people live longer, healthier and more active lives.  Central to all that they do are their talented and motivated professionals, circa 900 of whom are based at their Global Business Solutions centre in Little Island, Cork.  There they boast vibrant workforce made up of over 44 nationalities.

The Trial Capabilities Team provides clinical trial capabilities in support of clinical development. The Clinical Trial Start Up Associate is accountable to ensure the investigator sites meet requirements to enrol study participants into clinical trials and support ongoing activities during site maintenance and closeout.

Responsibilities:

1. Contract Negotiations:

• communicating and negotiating contracts with the appropriate site, team, or affiliate personnel (communicate on various contract issues, identify relationship-building opportunities, secure site contracts, collect site feedback, and facilitate communication with various personnel, communicate and negotiate more complex contracts)

2. TC Process Improvement and Training:

• maintaining and conducting contract-related training (develop and implement training for new contract associates and customers, create, maintain, and distribute contract templates, process documentation, and contract-specific documentation (such as the Legal Guidance Document) as the contract process owner, act as a mentor to the Contract Associates to provide the necessary guidance and knowledge transfer to allow the contract associates to be successful negotiators)
• providing clinical trial contract guidance to other business partners (develop process documentation, facilitate quality, speed and value through information sharing, , business partnership, and assurance that all guidance is aligned with company`s policies, clinical processes, and appropriate guidance, serve as the primary contact and process owner for interactions between TC and the Legal personnel related to process changes, documentation requirements, and site contracting issues)

3. Contract Process Improvements:

• identifying and implementing improvements to the contracting processes (standardizing and streamlining contract activities, as well as using metrics to drive improvement throughout the entire contracting process, increase contracting efficiency and effectiveness by ensuring that learning is shared and leveraged, anticipate changes by evaluating issues and opportunities, both internal and external, and making recommendations to TC management)

Requirements:

• Bachelor’s degree in a relevant discipline
• 3-5 years of experience negotiating contracts in clinical trials or similar
• Native Spanish speaker and fluency in English
• Strong organizational/time management skills, analytical skills, negotiation skills
• Strong critical thinking skills

Other Information/Additional Preferences:

• Advanced degree or legal degree
• Thorough understanding of GDPR and other privacy regulations
• Experience negotiating privacy clauses with clinical research sites
• Experience working with global business partners and a global team