The Associate Director (AD)/Senior Clinical Trial Manager (CTM) is responsible for the planning, implementation, vendor oversight and management of complex, multi-center clinical trials. The AD/CTM is accountable for the day-to-day operations of clinical trials including, but not limited to, feasibility, study start up, enrollment, and close out activities. The AD/CTM will manage the CRO and study vendors to ensure adherence to protocol, overall project timelines and budget, and performance of specific study activities as assigned. The AD/CTM will also contribute to developing and improving company standard operating procedures and processes and will be an active participant in cross functional internal meetings.
Key Duties & Accountability:
- Act as the clinical point person managing protocol execution, including the oversight of CROs, vendors and consultants that are involved with the clinical trials.
- Coordinate cross-functional efforts to achieve study objectives and goals.
- Ensure accurate tracking of study milestones, and reporting of study metrics and timelines.
- Identify and communicate study issues that will impact budget, resources, and timelines.
- Ensure study team adherence to ICH/GCP/Federal and local regulations and company-specific SOPs.
- Handle ongoing study communications and escalation of study-related issues as required.
- Participate in clinical/regulatory strategy meetings, study team meetings, and ad hoc clinical operations initiatives and programs.
- Assist in preparation and review of clinical documentation including but not limited to Informed Consent forms, Clinical Study Protocols, Investigator Brochure, Clinical Monitoring Plan, Pharmacy Manual, Communication Plan, etc.
- Ensure documentation prepared internally or by CRO and vendors is completed in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies.
- Oversee and track collection and shipments of study samples and specimens, as well as shipments of investigational product.
- Ensure the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic quality reviews.
- Oversee monitoring activities and conducts co-monitoring visits as needed.
- Assist with the development of the clinical components of regulatory submissions including, but not limited to: safety, interim and final study reports.
- Participate and respond to Quality Assurance and/or regulatory authority inspections and audits.
- Participate in reviews of scopes of work, budget, and vendor performance and issue resolution documents.
- Facilitate the development of clinical trial agreements and other relevant documents, ensuring coordination with the legal team.
- Assist in management of clinical trial budgets and provide ongoing financial reporting and projections to the finance team.
Education, Experience & Skills:
- Bachelor’s degree (or higher) in health sciences or related field.
- Minimum of 8+ years of experience in clinical research with direct experience managing Ph III trials. Clinical study monitoring and/or clinical study coordinator experience a plus.
- Experience in management of CROs, vendors and consultants.
- Documented training, knowledge and application of current FDA regulations and GCP and ICH guidelines in clinical trials.
- Experience developing clinical study plans including site monitoring, trial budgets, site selection and clinical supply management.
- Excellent written and verbal communication skills.
- Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
- Self-motivated, responsible and proactive.
- Effective use of time management including ability to work on multiple assignments simultaneously and meet deadlines.
- Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project.