Senior Site Contract Manager, Clinical Outsourcing
W2 Contract
Salary Range: $124,800 - $166,400 per year
Location: San Mateo County, CA - Hybrid Role
Job Summary:
We are seeking a motivated Site Contract Manager with Oncology experience to support all site contract and budget processes. You will be responsible for drafting, advising, negotiating, and executing clinical site agreements, ensuring final contracts and contract terms are consistent with organizational strategy, delivered by agreed-upon timelines, fall within Fair Market Value, and comply with legal, financial, and regulatory requirements.
Duties and Responsibilities:
- Manage a high volume of site contract agreements from start to finish. Support all site contract and budget activities related to clinical trials.
- Ensure consistency of contract terms with company policies, goals, and best practices to enhance the contracting process.
- Ensure smooth, timely, and accurate implementation of all contract terms.
- Be accountable for the timely preparation and execution of all site contracts and budgets.
- Enter contracts into our CMS.
- Provide input for ongoing updates of applicable legal contracts, budget playbooks, and templates.
- Ensure appropriate tracking of various agreements.
- Effectively escalate and communicate promptly to stakeholders and clinical teams regarding contract issues that could impact project deliverables.
- Lead process improvement projects and continuously improve the delivery of global Contract Management responsibilities.
- Ensure the execution of an end-to-end process is robust and established to effectively support key business partners' needs while continuously monitoring and further enhancing service quality, efficiency, and effectiveness, leading and supporting continuous improvement initiatives.
- Manage contract workflow and collaborate with senior leaders to ensure efficient contract execution and suggest and implement new, more efficient processes as needed.
- Measure and report metrics and Key Performance Indicators (KPIs) for in-scope service deliverables.
- Participation in team meetings and collaborate with other functional groups within the company to achieve clinical study goals.
- Ensure contracts and budgets are completed on time, within budget, and in compliance with Standard Operating procedures (SOPs), FDA regulations, and International Council for Harmonisation (ICH)/ GCP guidelines.
Requirements and Qualifications:
- B.S. and 5+ years of equivalent related industry experience
- Experience in pharmaceutical, biotech, academia, CROs (Clinical Research Organizations)
- 3+ years experience with clinical budget negotiation
- Experience in Oncology is required.
- Demonstrated experience with clinical budget build/development using (FMV), and historical data (Grant Plan). Strong negotiation of MCTA, ICTAs, CTAs, CSAs, CDAs, other site agreements and budgets with investigator sites (directly or with support where language necessitates), using appropriate templates, guidance, and legal/budget playbooks, liaising with ClinOps, Finance and legal for approval.
- Demonstrates a high level of applicable competencies in contract management and critical thinking; highly competent in negotiation and contracting business standards
- Strong computer skills in Microsoft Office and software to manage contracting
- Demonstrated leadership, stakeholder influencing without authority, and negotiation skills
- Strong knowledge of a wide variety of clinical-related contract types, including clinical trial site agreements, investigator-sponsored trial agreements, research collaboration agreements, consulting agreements, and confidentiality agreements
- Strong analytical and contract administration skills, verbal and written communication skills, and the ability to interact effectively with internal and external business partners
- A high degree of dedication, motivation, and ability to work under pressure with a drive for results
- Experience working in a global environment
- Strong working knowledge of FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
- Strong problem-solving skills with sound, technically driven decision-making ability.
- An innovative team player with the capacity to be effective in a dynamic and fast-paced company environment
- Grant Plan experience is a plus.
Desired Skills and Experience
Clinical site contracts, clinical, budget negotiation, clinical outsourcing, Oncology, contract management, clinical trial, pharmaceutical, biotech, CRO, FDA, ICH Guidelines, GCP, Microsoft Office, Grant Plan
Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.
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