Clinical Outsourcing and Contracts Manager
Neurocrine Biosciences
6 hours ago
Remote friendly (San Diego, CA)
United States
$119,700 - $164,000 USD yearly
Operations
About The Role
The Clinical Outsourcing and Contracting Manager is responsible for managing outsourcing and contracting activities in support of clinical research (primary focus: clinical trials). Partners with CROs and other vendors to ensure efficient, compliant, and high-quality execution of clinical programs.
Responsibilities
- Lead and manage Requests for Information (RFI) and Requests for Proposal (RFP) processes across all phases of clinical trials and related services
- Partner with clinical study teams for vendor selection; coordinate RFPs and bid defenses; negotiate work orders and change orders
- Lead and support outsourcing strategies, including supplier selection and ongoing supplier management
- Negotiate, administer, and execute complex agreements with global service providers, vendors, research collaborators, and clinical trial sites
- Ensure contracts comply with regulatory requirements, ethical standards, and company procurement policies
- Manage the full contract lifecycle from request intake through execution aligned with study timelines
- Review, draft, redline, and negotiate clinical agreements and templates
- Identify contractual risks, escalate issues, and drive resolution
- Negotiate favorable terms and budgets with a focus on cost control, risk mitigation, and preventing scope creep
- Partner with Finance/Accounting to review and manage contract budgets and payment terms
- Ensure accuracy, consistency, and compliance across contract documentation
- Monitor contract turnaround times and drive process improvements
- Contribute to continuous improvement of contracting, budgeting, and payment processes
- Perform other duties as assigned
Requirements
- BS/BA in business administration or health care/science + 6+ years in a CRO/Biotech/Pharmaceutical organization with contract management, negotiation, budgeting/administration (incl. billing/invoicing), issue resolution, and serving as a CRO point of contact
OR
- Master’s degree in business administration or health care/science + 4+ years in similar experience
- Strong knowledge of clinical trial processes, regulations, and industry guidelines
- Demonstrated experience preparing/negotiate external provider MSAs, work/change orders, and related clinical agreements
- Ability to read/interpret ensure contract language and terms align with company standards
- Strong contract administration skills (budgeting, billing/invoicing, issue resolution; point of contact for CROs/vendors)
- Knowledge of clinical contract accounting and budgeting processes
- Solid understanding of drug development and clinical operations
- Ability to work effectively in a matrixed, cross-functional organization
- Proven ability to manage multiple projects and deadlines accurately/efficiently
- Strong project management, organizational, analytical, and problem-solving skills
- Excellent interpersonal and communication skills
- Ability to assess broader organizational impact of contracting decisions
- Advanced proficiency in Microsoft Word, Excel, and Smartsheets
- Demonstrated commitment to process improvement and best practices
Benefits
- Annual bonus with target of 30% of earned base salary; eligibility for equity-based long-term incentive program
- Retirement savings plan (with company match)
- Paid vacation, holiday, and personal days
- Paid caregiver/parental and medical leave
- Health benefits: medical, prescription drug, dental, and vision
The Clinical Outsourcing and Contracting Manager is responsible for managing outsourcing and contracting activities in support of clinical research (primary focus: clinical trials). Partners with CROs and other vendors to ensure efficient, compliant, and high-quality execution of clinical programs.
Responsibilities
- Lead and manage Requests for Information (RFI) and Requests for Proposal (RFP) processes across all phases of clinical trials and related services
- Partner with clinical study teams for vendor selection; coordinate RFPs and bid defenses; negotiate work orders and change orders
- Lead and support outsourcing strategies, including supplier selection and ongoing supplier management
- Negotiate, administer, and execute complex agreements with global service providers, vendors, research collaborators, and clinical trial sites
- Ensure contracts comply with regulatory requirements, ethical standards, and company procurement policies
- Manage the full contract lifecycle from request intake through execution aligned with study timelines
- Review, draft, redline, and negotiate clinical agreements and templates
- Identify contractual risks, escalate issues, and drive resolution
- Negotiate favorable terms and budgets with a focus on cost control, risk mitigation, and preventing scope creep
- Partner with Finance/Accounting to review and manage contract budgets and payment terms
- Ensure accuracy, consistency, and compliance across contract documentation
- Monitor contract turnaround times and drive process improvements
- Contribute to continuous improvement of contracting, budgeting, and payment processes
- Perform other duties as assigned
Requirements
- BS/BA in business administration or health care/science + 6+ years in a CRO/Biotech/Pharmaceutical organization with contract management, negotiation, budgeting/administration (incl. billing/invoicing), issue resolution, and serving as a CRO point of contact
OR
- Master’s degree in business administration or health care/science + 4+ years in similar experience
- Strong knowledge of clinical trial processes, regulations, and industry guidelines
- Demonstrated experience preparing/negotiate external provider MSAs, work/change orders, and related clinical agreements
- Ability to read/interpret ensure contract language and terms align with company standards
- Strong contract administration skills (budgeting, billing/invoicing, issue resolution; point of contact for CROs/vendors)
- Knowledge of clinical contract accounting and budgeting processes
- Solid understanding of drug development and clinical operations
- Ability to work effectively in a matrixed, cross-functional organization
- Proven ability to manage multiple projects and deadlines accurately/efficiently
- Strong project management, organizational, analytical, and problem-solving skills
- Excellent interpersonal and communication skills
- Ability to assess broader organizational impact of contracting decisions
- Advanced proficiency in Microsoft Word, Excel, and Smartsheets
- Demonstrated commitment to process improvement and best practices
Benefits
- Annual bonus with target of 30% of earned base salary; eligibility for equity-based long-term incentive program
- Retirement savings plan (with company match)
- Paid vacation, holiday, and personal days
- Paid caregiver/parental and medical leave
- Health benefits: medical, prescription drug, dental, and vision