Contract Specialist II/Sr.

Clinical Operations Research Triangle Park, North Carolina


Description

Position at Premier Research Group Limited

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.

Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it! 

We’re looking for a Sr. Contract Specialist or Contract Specialist II to join our SSU department.

Imagine. Inspire. Innovate. Impact. With Us.

The Contract Specialist is responsible for all aspects of preparation, negotiation and execution of required contractual agreements associated with an investigative site participating in a clinical study.   The Contract Specialist assumes responsibility on quality deliverables throughout the conduct of the study with a concentration on Site Start Up.

RESPONSIBILITIES:

  • Is responsible for preparing, negotiating, tracking and finalizing the Confidentiality Agreements (CDA), Clinical Trial Agreements (CTA), Budgets and Letters of Indemnification (LOI) as well as Amendments to these documents, as needed.
  • Negotiates final CDA and CTA templates with clients, and the internal project team.
  • Manages all required contractual agreements with investigator sites. This includes distribution, negotiation of budget and language, finalization and tracking of all documents.
  • Independently communicates with client designee on all contract-related items.
  • Proactively identifies site contract related risks and potential roadblocks.
  • Prepares contract approval timelines with investigators and leads efforts to obtain contract approval to meet study deliverables.
  • Maintains communication with client, project team and sites regarding status of all contractual requirements.
  • Assists in development and implementation of new initiatives and negotiation/execution processes.
  • Collaborates with the project team to ensure the client deliverables and expectations are achieved.
  • Provides training on clinical site contractual requirements and negotiation.
  • Mentors and trains junior level staff.
  • Other activities as designated.

 EDUCATION, SKILLS & COMPETENCIES:

  • Undergraduate degree or its international equivalent in business administration, legal studies or life sciences from an accredited institution.

EXPERIENCE

  • 3+ years of experience with contract language, budget development and negotiations. Preferably clinical study related.
  • At least 2 years of related industry experience (CRO preferred)
  • Knowledge of basic requirements of contracts, non-disclosure agreements, powers of attorney and related documents
  • Knowledge of ICH / GCP regulations
  • Excellent team player, collaborative and builds an effective team
  • Ability to multitask and work effectively in a fast-paced environment with changing priorities
  • Strong verbal and written communication and negotiation skills
  • Excellent organizational and time-management skills, able to prioritize work to meet deadlines
  • Is customer service focused in approach to work, both internally and externally