Clinical Operations Manager
MEI Pharm, Inc., a is a San Diego-based oncology company focused on the clinical development of novel therapies for cancer. Our portfolio of drug candidates includes Pracinostat, an oral HDAC inhibitor that is being developed in combination with azacitidine for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Our clinical development pipeline also includes ME-401, a highly selective, oral PI3K delta inhibitor, voruciclib, an oral, selective CDK inhibitor, and ME-344, a novel mitochondrial inhibitor. MEI currently has an open position for a:
CLINICAL OPERATIONS MANAGER
The Clinical Operations Manager is a highly motivated professional able to manage global clinical trials; the individual will be an integral member of the clinical operations team whose work enables the company to meet defined goals for the clinical development program. He/she will be responsible for the execution of a clinical trial or suite of clinical trials from protocol design to the final clinical study report – utilizing best practices in order to ensure budgets, timelines and performance requirements are met. The position is responsible for coordinating all efforts for the trial both within the Company and through a wide variety of vendors.
Essential/ Primary Duties, Functions, and Responsibilities
- Responsible for trial conduct and quality at all levels (i.e., monitoring, data management)
- Create and maintain project timelines for each project and use these timelines to track and manage progress
- Manage relationships with existing and new CROs and other vendors, including managing timelines and budgets for outsourced study management activities. Coordinate all vendors’ activities involved in the clinical trials, e.g., central lab, CROs, including managing the RFP processes and overall budget for each.
- May assist in developing protocol concept sheet (study design, entry criteria and schedule of assessments table) and informed consent form templates.
- Review protocols, informed consent forms and CRFs and track development to completion
- Create project budgets and manage cost to budgets
- Review and approve the site contract template and budget template and review and approve any variations to the template
- Develop or review study-related support materials (e.g., Study Management Plan, Monitoring Plan, Data Management Plan)
- Ensure review of Clinical Trial Master File for completeness
- Conduct ongoing review of data for completeness and accuracy
- Ability to negotiate and manage competing priorities across multiple functional areas
- Ensure all functional groups provide deliverables (i.e., query generation and resolution, data base lock, study report). Inform all groups of deliverables and timeline, project developments and ensures completion according to timelines
- Prepare high-quality reports for management on program status and issues
- Ensure clinical trials are conducted in compliance with applicable ICH-GCP guidelines, SOPs and local regulatory guidelines or regulations
- Work independently, exercise appropriate judgment and coach other team members for effective communication
Education and Competency Requirements
- Bachelor degree in health or biological sciences or other scientific discipline
- Oncology therapeutic area experience strongly preferred
- Minimum of 5 years clinical study management experience in pharmaceutical/CRO industry
- Direct experience in managing clinical trials and prior management of contracted resources/CROs
- Previous experience in negotiating vendor/site contracts and management of budgets
- In depth knowledge of ICH-GCP guidelines and regulations and the ability to apply them
- Strong operational management with attention to detail
- Demonstrated capabilities and proven track record of problem solving skills
- Excellent communication skills (oral and written) and interpersonal skills
- Ability and willingness to travel up to 15% of time, including domestic and international travel
- Highly motivated team player willing to work and collaborate cross-functionally
- Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
- Regular communication (hearing/speaking).
- Lifting light-weight office supplies and equipment.
- Routine office duties including computer keyboard use
- Vision requirements include: close vision and ability to focus.
- Noise conditions range from quiet to moderate.