Responsible for supporting Clinical Operations’ management objectives to perform clinical trials that are of high quality, and that are delivered to agreed timelines and budget. This role manages clinical operationsprocesses including project planning, budget, resource management, and contract research organization management. This role also serves as a key contact and resource for Clinical Study Managers, CRA’s and Clinical Trial Assistants. Responsible for ensuring that clinical studies are effectively executed and delivered according to GCP and company SOPs. Assists with the creation and implementation of policies. Works cross-departmentally to ensure that the teams provide required inputs and receive updates to carry out clinical trials in an effective manner.
- Manages clinical operations teams and represents clinical operations on multi-function projects teams, internally/externally. Works with clinical investigators, other roles, and Clinical Service Providers (CSP) to develop, execute, and deliver clinical studies/programs that are of high quality.
- Ensures quality delivery of study enrollment within agreed budgets and timelines.
- Participates in the design/review of clinical protocols, case report forms, tools and tracking systems, and IXRS systems.
- Develops and manages relationship with critical and non-critical 3rd party vendors and clinical site staff; maintains ongoing documentation, performs risk analyses, and may participate in due diligence and in audit reviews.
- Effectively communicates project status and issues to management and the team.
- Prepares/oversees the preparation of all applicable documents required for the conduct of the study (Project Plan, Risk Management Plan, Monitoring Plan, Trial Master File (TMF)) etc.
- If a Contract Research Organization (CRO) is engaged, manages and reviews the work on an ongoing basis to ensure that tasks are performed to scope and budget.
- Liaises with other functional groups to ensure that timelines, budgets, and study objectives are met.
- Liaises closely with Clinical GCP group to ensure that quality metrics are met throughout the course of a trial.
- Oversees clinical study budgets.
- Provides day to day direction to Study Managers, and Clinical Trial Assistants to carry out their work.
- Ensures compliance with good clinical practices (GCP), good documentation practices (GDP), and regulatory guidelines.
- Recommends and implements innovative process ideas to positively impact clinical trials management.
- Other projects as assigned.
Bachelor’s degree in the life sciences or related field. An equivalent combination of relevant education and applicable job experience may be considered. Minimum 7 years’ progressively responsible pharmaceutical experience with a focus on clinical trials and early phase development. A minimum of 4 years’ experience in a leadership role. CNS therapeutic experience preferred.
- Knowledge and understanding of Good Clinical Practices (GCP) and other Clinical Trials Regulations and guidelines.
- Experience developing clinical protocols, SOP’s, Clinical Study Reports, and other documents to support New Drug Application (NDA).
- Demonstrated ability to successfully develop, implement, and manage clinical trials.
- Practical experience in clinical trial strategies, methods and processes; knowledge of clinical trial design.
- Demonstrated technical, administrative, and project management capabilities.
- Managerial courage (ability to be open, honest, and transparent when communicating with all levels of management.
- Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.
- Experience managing staff as well as mentoring and developing junior staff.
- Adaptable to changing priorities and ambiguous environment.
- Proficient computer skills, including Microsoft Word and Excel.
- Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the department or segments of the organization.
- Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals.