Lead Local Operations Manager – Oncology, Hematology
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Job Description
Lead Local Operations Manager responsible for operational strategy and delivery for oncology trials. Overseeing key performance metrics and mentoring local operations managers for clinical trial operations.
Responsibilities:
- Owns US site level operational delivery for assigned sites
- Leads and coordinates local trial team activities in compliance with SOPs, other procedural documents, and applicable regulations.
- Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget, including but not limited to: development of local trials specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
- Provides leadership oversight and mentoring support to other local operations managers assigned to the trial or program
- Shapes US trial operational strategy and integrates site insights into global feasibility and startup planning.
- Serves as the primary US operational interface to global trial leadership.
- Monitors country level operational KPIs and identifies systemic risks and mitigation strategies.
- Acts as escalation point for complex site contracting, operational, and recruitment issues.
- Represents US local operations at investigator and/or study coordinator site meetings and key governance forums.
- Acts as subject matter expert for assigned protocols and develops strong therapeutic knowledge to support roles and responsibilities.
- May represent Oncology Site Enablement on cross functional teams.
- Elevates US site insights to inform global decision-making and continuous improvement.
Requirements:
- A minimum of a bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related scientific discipline (or equivalent experience) is required; advanced scientific or clinical degrees are an advantage.
- Typically, a minimum of 4 years of experience in clinical trial operations, trial management, site management, or clinical monitoring, including significant experience in complex, high-priority, or multi-site trials.
- Demonstrated experience in oncology trial operations is strongly preferred
- In-depth understanding of the clinical development process and end-to-end trial delivery, with demonstrated expertise in feasibility, startup strategy, enrollment execution, quality oversight, and closeout.
- Strong and applied knowledge of GCP, regulatory requirements, inspection readiness, and compliance management, with experience supporting audits and regulatory inspections.
- Demonstrated leadership experience, including coaching, mentoring, and guiding other Local Operations Managers or site-facing roles in a player-coach capacity.
- Proven ability to lead through influence, resolve escalations, and drive alignment across cross-functional and global trial teams.
- Experience shaping or contributing to country-level or trial-level operational strategy, including site selection, enrollment forecasting, and risk mitigation planning.
- Strong analytical skills with the ability to interpret country- and site-level KPIs, identify systemic risks, and implement corrective actions.
- Excellent written and verbal communication skills in both the local country language and English, with demonstrated ability to represent the country or region in global forums.
- Willingness to travel up to 10% as required, including overnight stays and participation in investigator meetings and key trial governance meetings.
- Demonstrated flexibility, resilience, and ability to operate effectively in a highly complex, fast-changing clinical development environment.
Benefits:
- medical
- dental
- vision
- life insurance
- short and long-term disability
- business accident insurance
- group legal insurance
- consolidated retirement plan
- savings plan (401(k))
- vacation –120 hours per calendar year
- sick time - 40 hours per calendar year
- holiday pay, including Floating Holidays –13 days per calendar year
- work, Personal and Family Time - up to 40 hours per calendar year
- parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- caregiver Leave – 80 hours in a 52-week rolling period
- 10 days Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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