The Project Manager (PM) is responsible for the management of all aspects of Clinical Trial Team activities for assigned project(s). The PM is accountable for achieving successful delivery of clinical team activities at the project level by meeting company and regulatory requirements according to time, quality/scope and budget constraints.
To perform this job successfully, an individual must be able to perform the following:
- Proactively manage project level operational aspects of Clinical Trial Team (CTT) including management of trial timeline, budget, resources and vendors.
- Provide efficient updates on trial progress to the Clinical Program Director (CPD) and/or Senior Director of Clinical Operations (DCO), with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.
- Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Trial Team (CTT) to set priorities in accordance with applicable project plans, company standard operational procedures, ICH/GCP guidelines and regulatory requirements.
- Ensure potential study risks are escalated to the attention of the CPD when appropriate.
- Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.
- Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team
- Review and approve vendor invoices in collaboration with the Accounting team to ensure investigator payments occur in a timely manner
- Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.
- Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures
- Effectively provide support to Clinical Site Manager(s) in the conduct of the trials
Skills & Qualifications
- Five plus years of experience in Clinical Research domain
- Minimum 3 years of clinical operations experience as PM with increasing levels of responsibility, in the Pharmaceutical, Biotechnology, Medical Device or CRO industry is required.
- Bachelor's degree in Life Sciences, Nursing Licensure or Pharmacy, at minimum
- Read, write and speak fluent English,excellent verbal and written communication skills
- Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods