Study Contracts Manager

The Study Contract Manager (SCM) plays an important role in driving the costings and contracts with US Clinical research sites. They are responsible for negotiation and budgeting in clinical trials and for developing and managing contracts and annexes with investigators and institutions or external vendors ensuring ethical, fair and compliant practices. Primary responsibility lies site budget and agreement negotiation.

Duties and Responsibilities:

• Develop and negotiate clinical site budgets based on Fair Market Value. Leverage historical data, negotiation techniques, and address SoC with sites to realize cost savings.
• Negotiate agreement language with clinical study sites to reach a shared understanding of deliverables, a timely study start-up and financial obligations.
• Be responsible for producing clinical site budget appropriate Payment Schedules based on the Protocol and Client policy and guidelines to provide to Clinical Delivery Team.
• Formulate and identify the proper agreement template to initiate negotiations.
• Act as point of contact and interface with Legal if necessary to ensure integrity of contracts.
• Drive site start-up time by striving to execute CSA within KPI.
• For each agreement maintain the status of agreement, budgets, issues, and communications with both internal and external sources.
• Attend and engage in scheduled project team meetings.
• Ensure final contract documents are consistent with agreements reached at negotiations.
• Ensure all agreements are completed or captured in contracting system system
• Support internal and external audits and litigation activities.
• Negotiate appropriate terms and conditions of Informed Consent Forms and other Clinical Agreements and associated documents.
• Ability to process agreement requests and identify correct legal entity and template to be used.
• Approve Clinical Study Agreements with final signature, according to Delegation of Authority.
• Negotiate a variety of common contractual issues related to standard template agreements.
• Process amendments to contracts, as necessary, and manage that modification.
• Work with study teams to determine priorities for meeting timelines and SIV dates.
• Serve as a liaison between the legal and clinical trial teams.
• Negotiate master templates with preferred or notable Institutions.
• As a subject matter expert, exhibits contract and negotiation expertise to achieve a balance between external business exposure and policies/regulations.
• As a subject matter expert, demonstrates an understanding of how contractual terms add value to internal and external customers.
• As a subject matter expert, possesses detailed and in-depth knowledge of contract precepts, the contracting process and budget development.
• Communicate confidently and competently to liaise with others through excellent communication and negotiation skills.
• Demonstrate a strong understanding of how the contracting and budget processes contribute to Project Management practices (schedule/cost forecasting and risk management).
• Demonstrate accurate knowledge of regulations and policies in order to maintain and develop the effectiveness of the Clinical Study Agreement & Grant Management processes.
• Demonstrate ability to follow and work within processes.
• Ensure compliance with Company's Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).

Top Skills Details:

Contracts Negotiation, Budget Negotiation

Additional Skills & Qualifications:

• Minimum 2-4 years of Site Contract & Site Budget negotiation –1 of which must be at CRO or Sponsor level.
• Preferred software experience 1+ years of GrantManager
• Bachelor degree in related discipline, preferably in life science, law, finance or equivalent qualification.
• Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
• Good knowledge of relevant local regulations.
• Basic understanding of the drug development process.
• Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
• Excellent attention to details.
• Good written and verbal communication skills.
• Good collaboration and interpersonal skills.
• Good negotiation skills.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.