Summary of Responsibilities
This position is responsible for the clinical planning process and for all aspects of the management of clinical operations for one or more clinical trials including resource management. This position is responsible for clinical trial conduct including project planning, budget management, timelines, resource management, site management, monitoring, study management, vendor management, and project operational support. Performs assigned responsibilities to ensure timely completion of department goals and objectives with minimum supervision. Disseminates clinical information to the clinical team members and Associate Director as appropriate.
•Manages/oversees the conduct and execution of assigned clinical trials and associated activities in accordance with Good Clinical Practices (GCP) and relevant national and international requirements.
•Assist with the review and determination of appropriate site and vendor selection and ensuring all vendors meet the predetermined program milestones.
•Interacts with internal and external groups (CROs, vendors, clinical sites, etc.) to facilitate clinical trials and achieve designated timelines.
•Oversees study timelines, clinical trial budgets, coordinates development of study plans, CRF’s and other study reports and reviews and approves monitoring reports as appropriate. Reviews CRO site monitoring calendars, tracks site visits, tracks monitoring report issuance and receipt, conducts initial reviews of reports, to assure that full internal reviews are conducted on a timely basis.
•Oversees and participates in review of clinical trial data and clinical trial files. Provides clinical review of annual reports, IB updates.
•Participates in periodic review and revision of departmental policies and SOPs to assure compliance with GCP and corporate policies.
•Participates in special projects as appropriate.
•Maintains professional and technical knowledge by staying current on pharmaceuticals industry research and developments as appropriate; by utilizing the resources made available by the Company; and by sharing information with colleagues.
•Keeps management informed by escalating issues requiring intervention to the study and project teams under the supervision of the Associate Director/Director.
•Acts on constructive feedback by using feedback from peers, Supervisors, and colleagues to improve performance and ability to provide constructive feedback to direct reports and colleagues.
Minimum education requirements
7 – 10 Years
Knowledge & skills (general and technical)
•Bachelor’s degree from a four-year university or college; and 7 to 10 years work experience in the healthcare or clinical trial industry monitoring and managing clinical trials; or equivalent combination of education and experience.
•Extensive knowledge of clinical development principles, theories and concepts and knowledge of pharmaceutical industry practices and standards, including GCP.
•Familiarity with the lifecycle of a clinical trial: from protocol development and feasibility through study close-out and reporting.
•Ability to manage complex and global clinical trials.
•Excellent written and oral communication skills in order to effectively communicate in English. Ability to communicate in medical and scientific terms with vendors, consultants, and peers in English.
•Ability to read, analyze and interpret professional journals, technical procedures, and/or government regulations in English. Ability to write reports, business correspondence and procedure manuals in English.
•Ability to effectively present information to and respond to questions from groups of managers, sites, etc.
•Ability to solve problems and deal with a variety of concrete variables in situations where only limited standardization exists.
•Must be tactful, mature, flexible, and have well-developed interpersonal skills. Ability to get along well with different personalities and to work well in teams.
•Must have demonstrated ability to work independently and in a team, and provide leadership in a management role.
•Must have experience interfacing and managing multiple vendors/ contractors.
•Ability to manage time, multi-task and prioritize in order to complete deliverables on schedule.
•Computer skills needed include strong knowledge of database and word processing: MS Word, MS Project, PowerPoint, and Excel.