CAREER PORTAL

Clinical Study Lead

Position Title: Contract Study Lead – Clinical Operations (Oncology, Early Phase)
Location: Remote 
Type: Contract
Pay Range:$70-$97 DOE

About the Company:
We are a rapidly growing, clinical-stage biotechnology company focused on developing targeted therapies for cancer patients. Our mission is to translate scientific innovation into precision medicine solutions for high-need patient populations. Leveraging robust translational and biomarker strategies, we aim to advance therapies that are guided by genetic and molecular insights. Our collaborative and science-driven culture is built on curiosity, data integrity, and an unwavering commitment to patients.

Position Summary:
We are seeking a highly motivated and experienced Contract Study Lead to provide strategic and operational leadership for one or more early-stage clinical trials in oncology. This individual will independently manage cross-functional execution teams, vendors, and CRO partners to drive high-quality delivery of clinical programs from start-up through close-out.
You will serve as the main operational point of contact for internal stakeholders and external collaborators, playing a critical role in clinical planning, study conduct, and risk management. For the right candidate, this contract role may evolve into a permanent opportunity. Key Responsibilities:

• Lead and coordinate all aspects of regional/global clinical trial execution for early-phase oncology studies, ensuring timelines, budgets, and quality standards are met.
• Partner with cross-functional teams to initiate trials efficiently and maintain GCP and regulatory compliance throughout execution.
• Manage vendor selection processes (RFPs, bid defenses), oversee CROs and other clinical service providers, and monitor performance against KPIs.
• Lead development and review of essential trial documents including protocols, ICFs, CRFs, study manuals, and operational plans.
• Oversee study budgets and contracts, including forecasting, accrual tracking, invoice reconciliation, and managing work orders and change orders.
• Utilize and oversee clinical systems such as CTMS, TMF, EDC, and IRT for operational tracking and documentation.
• Monitor clinical data quality and support query resolution through review of listings and summary tables.
• Oversee site performance including monitoring activities, enrollment metrics, deviation tracking, and issue resolution in collaboration with CRO.
• Support study start-up, site selection, recruitment strategies, and inspection readiness.
• Maintain proactive risk identification and implement mitigation strategies in collaboration with cross-functional stakeholders.
• Build and maintain strong working relationships with investigative sites, CROs, vendors, and internal clinical and functional leads.
• Train investigators, study teams, and vendors on protocol specifics and operational expectations.
• Ensure TMF is audit-ready at all times and participate in audits or regulatory inspections as needed.

Qualifications:

• Bachelor’s degree in life sciences or related field required; advanced degree preferred.
• 8–10 years of experience in clinical trial operations, including global and domestic trial management. 
• Strong working knowledge of FDA, ICH, and GCP regulations and experience overseeing early-phase oncology trials.
• Experience managing CROs, vendors, budgets, and contracts in a dynamic, fast-paced setting.
• Demonstrated success in precision medicine or biomarker-driven clinical studies is highly desirable.
• Excellent problem-solving, communication, and interpersonal skills with a collaborative, team-oriented mindset.
• Strong organizational skills and ability to manage competing priorities effectively.
• Ability to travel for company meetings.

Estimated Min Rate: $67.90
Estimated Max Rate: $97.00


What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.