Sr. Manager/ AD, Clinical Trial Lead

Reporting to the Head of Clinical Operations, the Clinical Trial Lead (CTL) will lead and direct execution of clinical studies across multiple clinical programs. They will be responsible for overseeing the coordination, management, and operational aspects of assigned clinical studies to secure the successful completion of projects within prescribed time frame and funding parameters. The successful candidate will be responsible for the planning, implementation and conduct of clinical trials, or responsible for being the operational lead for a product and associated development program.

The Sr. CTL will oversee some or all elements of clinical studies with oversight. The successful candidate will have solid knowledge of the processes involving clinical studies, a broad understanding of essential study documentation, be highly adaptable, solutions oriented, and can prioritize and manage timelines and key deliverables.

The Associate Director will additionally be expected to provide leadership within the Clinical Operations department and make recommendations with regards to the strategic aspects of clinical programs. They will work cross-functionally to identify and evaluate issues in the programs, interprets data on complex issues, make good business decisions and suggest and implement solutions. The Associate Director, with support from the Head of Clinical Operations, will be accountable for ensuring that all project deliverables meet the corporate and department expectations.

Responsibilities (Sr. CTL)

• Participates in the internal cross-functional study team(s); Serve as key contact to other groups outside of Clinical Operations involved and contributing to the operational aspects of clinical trials
• Participate in the selection and management of contract research organizations (CROs) and other outside vendors to support clinical studies
• Manages external vendors, including CROs, central laboratories, and other external service providers, as necessary, from study start-up through final clinical study report
• Assists in the preparation and review of the Protocol, Informed Consent, Case Report Forms and associated completion guidelines, and other study documents
• Manages study timelines, budgets, and quality metrics in accordance with corporate objectives and goals
• Lead and oversee study activities from study startup through closeout
• Participate in the preparation and negotiation of clinical site and assigned CRO budgets and track variances
• Adheres to standards and processes in compliance with applicable GCP/ICH guidelines and other regulatory requirements
• Develops and maintains relationships with investigators and site personnel to support clinical study activities, including subject recruitment, and ensures protocol and regulatory compliance
• Communicates study trends, issues, mitigation plans, and lessons learned to management
• Manages study-related quality metrics
• Manages multiple initiatives and shifts priorities within a small company environment
• Provide routine updates to project team on study status/issues

Responsibilities (Associate Director)

• Participate as a member of the Clinical Operations team involved in defining the strategic direction of the clinical development path for various trials
• Manage internal clinical program staff and CROs, ensuring GCP compliance, proper training and staff development as appropriate
• Lead clinical operations activities and process improvement initiatives; is the key individual to communicate updates to all team members involved
• Keep up to date with industry practice and communicates key message back to team and provides recommendations accordingly
• Able to present at departmental and interdepartmental meetings
• Actively participate in the departmental goal setting and ensures individual goals align with the overall corporate goals
• Be able to lead direct reports, and oversee the work of others including mentoring of staff on all assigned projects

Qualifications

• Bachelor’s Degree.
• CTL: 4-6 years of experience in clinical development.
• AD: 6-8 years of experience in clinical development
• Prior employment at a biotech in similar role preferred.
• Experience managing complex schedules and priorities in dynamic environments.
• Ability to influence others and work independently and in a team environment.
• Driven and self-motivated with the ability to lead and facilitate priorities and activities across internal and external cross functional teams.
• Agility, to quickly adjust and navigate shifting priorities, demands and timelines.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
• Excellent computer skills (Microsoft Office Word, Excel, Outlook) required.
• Remote/Hybrid