Associate Director, Clinical Operations

Company: Nomis Solutions
Location: Cambridge
Posted on: September 15, 2020

Job Description:

The Associate Director is accountable for the oversight of a full development program and their direct reports on the Clinical Operations team. They are well versed in knowledge of operational methodologies, clinical research, ICH/GCP Guidelines, program management and delegation to/oversight of Clinical Trial Managers. They are responsible for the development of the clinical timelines, and are the co-author of the individual study timelines/deliverables/milestones

Duties and Responsibilities:

Have the skillset and experience to manage (or oversee the execution of) all related study start up, maintenance and close out activities

Create and maintain Program Budget forecast and execution, including a Clinical Development Plan, with program oversight of all aspects of the clinical development budgets of all studies within their program

Responsible for the clinical operations program development, the related clinical timelines and study timelines/deliverables/milestones

Have experience with and the ability to prioritize day to day issues and overarching goals with a keen eye to (understanding of) ICH/GCP Guidelines, escalating to Upper Management as appropriate

Assist with RFP generation, vendor selection, review of SOWs and Change Orders, as well as acting as a point of escalation for vendors within their clinical program

Contribute to and assist in maintaining a quality-focused clinical infrastructure by assisting in development, revision and/or implementation of SOPs consistent with the organization’s day to day execution of trials such that operational processes, systems and standards are consistent with GXP and are adopted, implemented and documented consistently across trials and programs

Maintain direct reports, regular meetings and oversight as well as complete all yearly review activities; Review and sign off on direct report’s documents

Train and mentor junior staff on Clinical Operations processes and the related execution of GCP and ICH guidelines such that compliance is the top priority, followed closely by excellent execution of all responsibilities

Lead process improvement initiatives, helping to maintain best practices and lessons learned across programs

Qualifications:

Bachelor’s Degree in a related field with at least eight years’ experience in the biotech and/or pharmaceutical industries, with at least seven years in clinical operations

Global clinical trial/Program Management and Phase I experience are both necessary, as is experience in Oncology and/or Rare Disease development

Track record of effective management of multiple projects/priorities and budgets in early to late phase development

Thorough understanding of GCP/ICH Guidelines, global regulatory requirements and strategic implications for downstream clinical development

Extensive vendor oversight and management experience, including negotiations and contract execution

Excellent interpersonal and communications skills (verbal and written), as well as problem solving skills

Demonstration of strong management abilities and mentoring skills, with prior experience managing, mentoring and training Clinical Operations staff

Ability and willingness to travel up to 20% (domestic and international)

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Keywords: Nomis Solutions, Cambridge , Associate Director, Clinical Operations, Other , Cambridge, Massachusetts