Clinical Contracts Manager

Actalent; Deutschland; Hybrid; EUR 225.312.000 - 249.029.000; Vollzeit

Zusammenfassung

Actalent is seeking a Clinical Contracts Manager to oversee vendor selection for CROs, central labs, and imaging providers. You will manage RFI/RFP processes, negotiate terms, and coordinate with Finance and Legal on costs and amendments.

You will develop per-site budgets, monitor KPIs, and support governance meetings. The role requires GCP/FDA/ICH knowledge and 5+ years in biotech/pharma outsourcing.

Qualifikationen

• Minimum 5 years of site budget and outsourcing experience in the biotech or pharmaceutical industry.
• Experience developing, negotiating, and managing clinical trial site budgets.
• Experience with CRO and vendor contract negotiation and financial management.
• Working knowledge of Good Clinical Practice (GCP), FDA regulations, and ICH guidelines.
• Working knowledge of Medicare Coverage Analyses and CMS National Coverage Determinations.
• Advanced proficiency in embedding AI as a tool into workflows and projects.

Aufgaben

• Identify and select Clinical Development vendors, including CROs, central labs, and imaging vendors.
• Manage documents and processes for selecting contract service providers, including RFI/RFP development, bid grid analysis, and stakeholder recommendations.
• Negotiate contract business terms, scopes of work, master service agreements, pricing, and payment schedules within approved parameters.
• Assist Clinical Development teams in defining, reviewing, validating, and negotiating vendor change orders and amendments.
• Collaborate with Finance and Legal to provide insights into incremental costs and highlight contractual issues.
• Monitor vendor performance against contractual KPIs/SLAs and maintain oversight documentation.
• Participate in vendor governance meetings and manage day-to-day vendor relationships.
• Support Finance/Accounting with general contracting queries, payment schedule interpretation, and contract burn management.
• Build and validate per-patient and per-site budget models using fair market value industry benchmarking data.
• Review, negotiate, elevate, and maintain clinical trial site budgets and investigator grants across assigned studies.

Kenntnisse

Vendor management

Budget negotiation

Clinical outsourcing

GCP/FDA/ICH knowledge

AI in workflows

Ausbildung

Bachelor's degree

Jobbeschreibung

Job Title: Clinical Contracts Manager

We are seeking a highly skilled Clinical Contracts Manager to oversee the identification and selection of Clinical Development vendors, including Contract Research Organizations (CROs), central labs, imaging vendors, and other specialty service providers. The successful candidate will manage the documentation and processes necessary to select the optimal contract service provider, ensuring efficient and compliant execution of contractual documents.

Responsibilities

• Identify and select Clinical Development vendors, including CROs, central labs, and imaging vendors.
• Manage documents and processes for selecting contract service providers, including RFI/RFP development, bid grid analysis, and stakeholder recommendations.
• Negotiate contract business terms, scopes of work, master service agreements, pricing, and payment schedules within approved parameters.
• Assist Clinical Development teams in defining, reviewing, validating, and negotiating vendor change orders and amendments.
• Collaborate with Finance and Legal to provide insights into incremental costs and highlight contractual issues.
• Monitor vendor performance against contractual KPIs/SLAs and maintain oversight documentation.
• Participate in vendor governance meetings and manage day-to-day vendor relationships.
• Support Finance/Accounting with general contracting queries, payment schedule interpretation, and contract burn management.
• Build and validate per-patient and per-site budget models using fair market value industry benchmarking data.
• Review, negotiate, elevate, and maintain clinical trial site budgets and investigator grants across assigned studies.

Essential Skills

• Minimum 5 years of site budget and outsourcing experience in the biotech or pharmaceutical industry.
• Demonstrated experience in developing, negotiating, and managing clinical trial site budgets.
• Experience with CRO and vendor contract negotiation and financial management.
• Working knowledge of Good Clinical Practice (GCP), FDA regulations, and ICH guidelines.
• Working knowledge of Medicare Coverage Analyses and CMS National Coverage Determinations.
• Advanced proficiency in embedding AI as a tool into workflows and projects.

Additional Skills & Qualifications

• Bachelor of Science or Bachelor of Arts degree.
• Experience with oncology trials, including cell therapy, CAR T, or other complex trials.
• Direct clinical site experience and navigating ex-US sites from a sponsor perspective is a plus.
• Ex-US experience is beneficial.
• Prior leadership and managerial experience in clinical outsourcing.

Work Environment

The work environment involves collaboration with Clinical Operations to facilitate interactions with CROs and clinical sites. The role requires adherence to industry standards and regulations, and the ability to negotiate and manage complex budgets and contracts effectively.

Hybrid in SF or WA

Job Type & Location

This is a Contract position based out of South San Francisco, CA.

Pay and Benefits

The pay range for this position is $96.00 - $96.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your jobclassification and length of employment. Benefits are subject to change and may besubject to specific elections, plan, or program terms. If eligible, the benefitsavailable for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in South San Francisco,CA.

Application Deadline

This position is anticipated to close on Sep 17, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.