ABOUT THE ROLE
As Senior Clinical Trial Manager (Sr. CTM), you’ll be responsible for the successful design and day-to-day execution of clinical trials from the protocol concept through publication. You ensure completion of study deliverables, typically work on studies that are either internally driven or investigator initiated, proactively identify and resolve clinical project issues and participate in process improvement initiatives. You’ll engage with study investigators, vendors and external stakeholders.
In addition, you will:
- Assist in the process of protocol finalization and manages all aspects of study execution. Use operational and therapeutics expertise to optimize trial design and execution.
- Manage operational plans and timelines to achieve on-time enrollment and study completion. Identify barriers to timely and successful study execution and proposes solutions to same, with regular reporting of study performance metrics.
- Manage Contract Research Organization (CRO) relationships and contracts for study execution where applicable.
- Assist with management and/or execution of site training and ongoing educational interventions to assure compliance with study protocols.
- Assure compliance with all regulatory requirements. Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management.
- Drive data collection, clinical trial database construction, and assists with necessary audits of data to ensure data validity.
- Develop and manage study budget and maintain it within financial goals; review and approve clinical invoices against approved budget.
- May have direct reports such as CTAs and/or CTMs.
- Maintain proficiency in understanding of molecularly targeted therapies in oncology and an in-depth knowledge of genomic alterations in different cancers.
You are a seasoned clinical operations professional with a proactive mindset and an ability to find great solutions to complex problems cross functionally. You have had experience in the oncology space in pharmaceutical or biotech development, and we see clinical experience, cancer center, inpatient/outpatient or physician office experience as a plus. You work to maintain your therapeutic knowledge. You have solid organizational and business assessment skills and over time, you’ve demonstrated an ability to develop productive working relationships across functions and with external partners/teams. You work very well with minimal direction and seek out answers or collaboration where you need them.
You have excellent written and verbal communication skills. You’re known to have a strong problem solving ability and a flexible and solution-seeking attitude.
In addition, you have:
- Bachelor’s degree (or higher) in science or health-related discipline
- 7+ years of clinical trial experience in Pharmaceutical, Biotech or CRO company. 3+ years direct trial management experience, preferably including clinical team management.
- Strong understanding of GCPs, ICH, and knowledge of regulatory requirements
- Ability and willingness to travel 25%-50% of the time.
- Excellent knowledge of MS Office, project management and clinical trials software