Principal Specialist, Site Contracts
- Experience Level
- Experienced (non-manager)
We are seeking a Principal Specialist, Site Contracts to join our growing team!
This is a full time, permanent role that is home-based. This role can be based anywhere in the CIS, Nordic EU countries or Italy.
The Principal Specialist, Site Contracts is responsible for providing senior 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.
Tasks may include but are not limited to:
- Serves as a Lead and subject matter expert on Clinical Trial Agreement processes at the project level.
- Develops and provides expert and strategic pathways for the successful site contract execution within a project/program.
- Presents sites contract negotiation processes on kick-off/alignment meetings.
- Communicates and facilitates sites contracting strategies, contract turnaround/execution timelines, and sites contract tracking requirements.
- Agrees and negotiates Clinical Trial Agreements templates, fall back language and sites budget negotiation parameters with project lead and Sponsor.
- Supervises and mentors allocated Site Contracts Specialist, ensuring effective planning, effective communication, on time issues escalation, problem solving and execution.
- Recognizes potential problems/areas of concern and formulates contingency plans during the early stages of Clinical Trial Agreement development and escalates appropriately.
- Develops and implements mitigation plan to ensure the Clinical Trial Agreement deliverables are met.
- Resolves sites contracts negotiation issues.
- Prioritizes effectively and responds to urgent requests within the internal team or Sponsor.
- Works closely with the Regulatory Affairs Lead, Site Activation Lead and/or other departments 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 ICH-GCP Guidelines, local regulatory requirements, Worldwide SOPs and project specific procedures; maintains and assures the quality of work generated.
- Negotiation and finalization or assistance in negotiation and finalization of Site Contracts with Worldwide Legal Department, project team, Sponsors, investigators and/or clinical sites, as well as amending and terminating such contracts.
- Provides ongoing mentorship and training to Site Contracts Specialists, as needed.
- Provides input to drive continuous improvement in all aspects of site contracts activities.
- Assists in the development and maintenance of departmental processes, policies, SOPs, and associated documents.
- Assists the Site Contracts Manager and/or other company departments in leading or participating in departmental initiatives, tasks forces, and additional training where necessary.
- Completes routine administrative tasks in a timely manner (e.g. Timesheets, metrics, travel expense claims).
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
- Extensive knowledge regarding global requirements in regards to Clinical Trial Agreements requirements and negotiations.
- Extensive knowledge regarding Worldwide Site Contracts SOPs, WIs, internal tools, and related processes.
- Ability to review and understand technical, medical and legal documents related to Clinical Trial Agreements.
- Excellent leadership skills with the ability to work in a fast-paced, deadline-oriented, and changing environment
- Strong negotiation, planning, strategizing, mentoring, monitoring, scheduling, diplomacy, critiquing and problem-solving skills
- Excellent written and verbal communication skills, including negotiation skills and knowledge of Clinical Trial Agreements to clearly and concisely present information.
- Excellent interpersonal, verbal and written communication skills
- Ability to motivate both individuals and a team.
- Ability to successfully work in a “virtual” team environment
- Ability to complete tasks in an accurate, timely manner and effectively manage multiple tasks
- Effective time management in order to meet daily metrics or team objectives
- Shows commitment to and performs consistently high-quality work
- Ability to identify and address issues proactively in a timely manner
- Ability to take initiative, work independently and delegate
- Accountability for all assigned tasks
- Excellent computer and internet skills including knowledge of MS- Office products such as Excel, Word
- Bachelor's degree or equivalent in business administration, law, science or related field.
- Adept knowledge of biopharmaceutical/CRO industry and applicable local regulatory requirements.
- Knowledge and understanding of ICH and GCP Guidelines, as well as local regulatory requirements.
- Excellent verbal and written English language skills.
- A high degree of organizational, analytical, and team management skills.
- 2-3 years of experience as a Senior Site Contracts Specialist or a minimum of 5 years of Site Contract experience.