Global Clinical Trial Lead
Remote
Full Time
Experienced
Job Title: Global Clinical Trial Lead (Clinical Trial Manager [CTM]/Senior CTM)
Department: R&D: Clinical Operations
Reports To: Global Clinical Program Lead
Department Code: 4310
People Manager: No
FLSA Status: Exempt
Location: Remote / In-house with 25% Travel
Summary
The Senior Clinical Trial Manager (Sr. CTM) provides oversight of the operational aspects of the planning, execution and completion of assigned Phase I through III clinical trials including: ensuring alignment of activities with study timelines, budgets, SOPs, GCP and applicable regulatory guidelines. The Sr. CTM leads the cross-functional clinical trial team and partners with internal and external team members/key stakeholders ensuring alignment of activities with study projects and timelines to include, but not limited to: CRO and vendor selection, contracting, and management; inspecting and monitoring CROs; clinical trial protocols and patient recruitment; system design and activation; risk mitigation plans and assessments; reporting and metrics; and safety events and reporting.
Responsibilities
About Longboard
At Longboard Pharmaceuticals, our mission is to enhance the lives of individuals battling profound neurological conditions. Collaboratively, we foster an inclusive company culture and an inviting environment that we take immense pride in. We actively seek dynamic, talented, and dedicated individuals to join our team.
Pay Transparency
The expected salary for candidates who work in La, Jolla, CA is $160,000.00-$185,000.00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Longboard Pharmaceuticals, Inc is a multi-state employer and will consider candidates based in remote work locations.
Benefits
At Longboard, we prioritize the well-being and satisfaction of our employees, understanding that benefits play a crucial role in their overall compensation and life quality. We take pride in providing a robust suite of benefits designed to safeguard the health and happiness of our team members, their families, and their lifestyles.
Our benefits currently include:
Department: R&D: Clinical Operations
Reports To: Global Clinical Program Lead
Department Code: 4310
People Manager: No
FLSA Status: Exempt
Location: Remote / In-house with 25% Travel
Summary
The Senior Clinical Trial Manager (Sr. CTM) provides oversight of the operational aspects of the planning, execution and completion of assigned Phase I through III clinical trials including: ensuring alignment of activities with study timelines, budgets, SOPs, GCP and applicable regulatory guidelines. The Sr. CTM leads the cross-functional clinical trial team and partners with internal and external team members/key stakeholders ensuring alignment of activities with study projects and timelines to include, but not limited to: CRO and vendor selection, contracting, and management; inspecting and monitoring CROs; clinical trial protocols and patient recruitment; system design and activation; risk mitigation plans and assessments; reporting and metrics; and safety events and reporting.
Responsibilities
- Leads the clinical operations team (CRAs and CTAs) and cross-functional clinical trial in all operational aspects of one or more pivotal studies from start-up to close-out; proactively identifies and resolves operational issues ensuring alignment of activities with study timelines, budgets, SOPs, GCP, and applicable regulatory guidelines
- Manages and provides day-to-day oversight of full service CROs and third-party vendors including identification and selection of CROs/vendors, set-up, logistics, and documentation
- Responsible for the trial level clinical operations budget, invoices, and change orders, including developing and managing Statements of Work (SOW), site budgets, investigator payments, CTAs, etc.
- Participates in investigational site feasibility activities and selection of investigative sites
- Manages recruitment efforts and activities to meet study enrollment goals and timelines, and provides status to upper management
- Responsible for clinical trial material (CTM) label review and approval and assisting with CTM forecasting
- Develops and maintains study timelines, enrollment dashboards and status reports for senior management
- Proactively identifies and resolves operational issues/processes to ensure achievement of study milestones, data quality, and data integrity; escalates study-related issues appropriately in a timely manner
- Manages and contributes to the development of clinical documentation including but not limited to study protocols, Informed Consent (ICF), Study Reference Binder, Study Management Plan, Monitoring plan, Pharmacy manual, Lab manual etc.
- Interacts with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Safety, Clinical Supply (Investigational Product), and clinical vendors (e.g., central laboratory, CROs), as needed, to support clinical trial activities
- Participates in IRT, EDC, and ePRO design and user acceptance testing
- Oversees team engagement with CRO regarding clinical site oversight, data entry and cleaning timelines and assists with resolving site issues
- Participates and provides input to protocol, statistical analysis plan (SAP), tables, figures, data listings, protocol deviation reporting and clinical study report reviews
- Participates in data cleaning, data listing reviews and reconciliation and data analytics
- Contributes to and may lead the development of presentations for clinical sites, team and investigator meetings
- Responsible for oversight of study budget, investigator and vendor contracts, budgets, and payments
- Provides oversight for the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and audit-ready
- Performs other work-related duties as assigned or required
- Demonstrates interpersonal versatility, able to simultaneously serve as an individual contributor and a leader
- Thinks strategically and tactically
- Ability to manage trial(s) independently with minimal oversight
- Assists with mentoring less experienced Clinical Trial Managers and Clinical Operations team members; assists with team development
- Bachelor’s degree
- 8+ years of relevant and progressive clinical trial management experience
- Experience in full-cycle drug development
- Global phase III clinical trial experience preferred
- Strong understanding of clinical trials processes, protocols, and medical terminology
- Strong experience utilizing CTMS, EDC, TMS, and related software
- Prior experience in management and monitoring of CRO and investigative sites
- Strong experience with patient recruitment, non-compliance, safety, document management, an investigational product, IP accountability, and budget management
- Broad knowledge of ICH, GCP, IRB/IEC, and local regulatory authority drug research & development regulations
- Advanced experience with bio-samples, storage of 3rd party data
- Motivated to work in a fast-paced, high accountability environment
- Travel up to 25%
About Longboard
At Longboard Pharmaceuticals, our mission is to enhance the lives of individuals battling profound neurological conditions. Collaboratively, we foster an inclusive company culture and an inviting environment that we take immense pride in. We actively seek dynamic, talented, and dedicated individuals to join our team.
Pay Transparency
The expected salary for candidates who work in La, Jolla, CA is $160,000.00-$185,000.00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Longboard Pharmaceuticals, Inc is a multi-state employer and will consider candidates based in remote work locations.
Benefits
At Longboard, we prioritize the well-being and satisfaction of our employees, understanding that benefits play a crucial role in their overall compensation and life quality. We take pride in providing a robust suite of benefits designed to safeguard the health and happiness of our team members, their families, and their lifestyles.
Our benefits currently include:
- Hybrid work schedule out of our La Jolla office, 2-3 days a week
- Competitive compensation package including bonus opportunities and stock options
- Medical, Dental & Vision Plans
- 401(k) Plan, including company match with immediate vesting
- Flexible Time Off, including one week off in the summer and one week off around December holidays
- 11 paid company holidays per year
- An opportunity to do truly meaningful work to make a lasting impact
- Longboard Perks (on-site gym, garage parking, company-sponsored events, etc.)
- Flexible spending account for medical care
- Life insurance, short and long-term disability plans
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