Senior Manager/Associate Director, Clinical Operations
Editas Medicine, United States

Key Responsibilities amp; Accountabilities:

The Associate Director Clinical Operations is a responsible member of the compound development team dedicated to the development and execution of clinical trials and the clinical and operational implementation of one or more complex compound programs. These responsibilities include:

• Assist with the conduct of all clinical trials.
• Assist with facilitation of confidentiality agreements, study agreements with sites and external vendors.
• Develop and actively manage clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and working with investigational sites to meet, and whenever feasible, exceed enrollment targets.
• Assist with the writing/reviewing/approving clinical project deliverables such as investigational product labeling, pharmacy manuals, informed consents, IRB submissions/approvals, site activations, CRFs, DMP, edit checks, safety plan, DMC charter, and close-out plans.
• Assist with the identification and evaluation of investigators and investigative clinical trial sites and execute/supervise the completion of clinical trial feasibility studies.
• Assist with all site initiation activities including site initiation visits, investigator meetings, development and implementation of monitoring plans and annotated monitoring visit report templates and completion and submission of all required clinical trial documents prior to site initiation.
• Coordinate Institutional Review Board/ Ethics Committee (IRB/EC) approvals, as appropriate.
• Assist with oversight for clinical trial monitoring activities in accordance with Editas Medicine and ICH/GCP standards and in compliance with the approved monitoring plan and SOPs.
• Maintain the Clinical Trial Master File in concert with development partners and/or CROs for all Editas Medicine Clinical programs to ensure accuracy and completeness of the documentation.
• Ensure that all sites and CROs are audit ready.
• Provide oversight of all Contract Research Organizations (CROs).
• Manage study milestones and study metrics.
• Provide regular study updates and trial status to the Sr. Director, Clinical Operations.

Requirements

Knowledge, Skills amp; Capabilities:

• A complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required.
• Experience in Hematology/Oncology, Neurology, Immunology, Ophthalmology and Rare Disease Drug Development preferred and familiarity with gene and/or cell therapy.
• Experience with all phases of clinical drug development including global regulatory submissions preferred.
• Strong communication, organizational and interpersonal skills are required.
• Successful work experience in a matrix team environment with cross functional teams is required.
• Independent decision-making and analytical skills are required to operationalize and move the clinical trials forward.
• Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities.

Education amp; Relevant Work Experience:

• A minimum of a Bachelors’ Degree is required preferably in a Scientific or Technical Discipline. Advanced degree (MS, RN, PhD or PharmD) is preferred.
• A minimum of 10 years of experience in the Clinical Research amp; Development/Clinical Trials environment is required with a minimum of 2 years of clinical trial monitoring experience required.

Physical amp; Travel Requirements:

• Ability to travel up to 20% of time both domestic and/or international.

Job Rewards and Benefits