Lead Local Trial Manager

Role Description

We are searching for the best talent for a Lead, Local Trial Manager to be located remotely in the United States.

A Lead, Local Trial Manager is considered a senior trial management role with at least 4 years of clinical trial management experience or more than 6 years of clinical monitoring experience. This role is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries.

The Lead, Local Trial Manager is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents.

The Lead, Local Trial Manager is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.

What you will be responsible for:

• Lead country protocol feasibility and site feasibility assessment in conjunction with CTA, SM, and TDM/TDL.
• Implement local criteria for site selection and ensure consistent conduct of Site Qualification Visits.
• Collaborate with the Program Delivery Leader (PDL), TDM/TDL, local management/Country Head, and other study team members to select the final site list.
• Contribute input to study management documents at a country level or initiate development of these documents for a single country trial.
• Lead and coordinate local trial team activities in compliance with SOPs and applicable regulations.
• Ensure that all Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within required timelines.
• Maintain and update trial management systems and analyze trial progress using available study tools.
• Monitor country progress and initiate corrective and preventive actions (CAPA) when the trial deviates from plans.
• Submit requests for vendor services and support vendor selection.
• Assist in negotiation of trial site contracts and budgets as needed.
• Attend/participate in Investigator Meetings and may conduct local/country investigator meetings.
• Conduct local trial team meetings and provide or facilitate SM training when needed.
• Review and approve Monitoring Visit Reports submitted by SM and identify issues across a trial project.
• Review and approve site and local vendor invoices as required.
• Prepare country-specific informed consent in accordance with procedural documents/templates.
• Organize and ensure IEC/HA approvals and compliance with local regulatory requirements.
• Work with SM to ensure CAPA is implemented for audits and inspections.
• Act as subject matter expert for assigned protocols and develop strong therapeutic knowledge.
• Establish and maintain excellent working relationships with external and internal stakeholders.
• Lead or contribute to process improvement, training, and mentoring of CTAs, SMs, and other LTMs.
• Expected to assume additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”.

Qualifications

• A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences, or related scientific field is required.
• Minimum of 6 years of clinical trial management experience or a total of at least 8 years of clinical trial monitoring and/or clinical trial management experience.
• Oncology experience is required.
• In-depth understanding of the drug development process including GCP and local regulatory requirements.
• Willingness to travel with occasional overnight stay away from home.
• Minimum of 4 years of leadership experience.
• Computer skills required.
• Proficient in speaking and writing the country language and English language.
• Excellent written and oral communication skills.
• Demonstrated ability to be consistently influential.
• Strong experience in mentoring/coaching and providing training to other LTMs, SMs, and CTAs.
• Demonstrated ability to lead initiative/small teams.
• Flexible mindset and ability to work in a fast-changing environment.
• Ability to work on multiple trials in parallel in different disease areas, if required.
• Ability to anticipate obstacles and proactively provide solutions.
• Expected to be assigned to high priority and high complexity projects.

Requirements

• The anticipated base pay range for this position in the US is $109,000 - $174,800.
• The anticipated base pay range for the Bay Area is $125,000 - $201,250.
• This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
• Employees and/or eligible dependents may be eligible to participate in various Company sponsored employee benefit programs.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for vacation, sick time, holiday pay, and personal time off benefits.

Benefits

• Vacation - up to 120 hours per calendar year.
• Sick time - up to 40 hours per calendar year; for employees in Washington - up to 56 hours per calendar year.
• Holiday pay, including Floating Holidays - up to 13 days per calendar year.
• Work, Personal and Family Time - up to 40 hours per calendar year.