Clinical Manager
Premier Research - Florida

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Responsible for supporting the Project Manager or more Senior Manager within CTM with daily management of all phases of clinical studies involving multiple therapeutic areas. Leads the monitoring team and is responsible for the successful conduct and completion of the project according to the contract, budget and timelines. Ensures clinical study is conducted in accordance with all protocols, ICH-GCP/ISO14155, company policies, quality standards and all applicable local laws and regulations.

Supports Project Management in the development and review of the protocol/study design, case report forms, informed consent forms and other documents

Participates in the identification and recruitment of investigators; develops patient recruitment strategies and materials

May assist or manage regulatory and IRB/EC submissions

Coordinates Clinical Monitors on-site and in-house monitoring responsibilities, schedules and overall project related day-to-day management of the monitoring team

Manages aspects of the clinical projects, including development of the Project Operations Manual (POM) and the Clinical Monitoring Plan (CMP) and the review and sign-off of monitoring reports (including tracking of reports and assurance of visit frequency per CMP/contract); assists in preparation of the monthly status report

Assists in generation of CRF guidelines

Identifies, recruits and manages central vendors as required per project scope

May supervise Clinical Assistant(s) assigned to project teams for project related scope

Ensures study master files comply with SOPs, GCPs and local laws and regulations

Prepares for and attends project team meetings and provides updates of project performance

Designs and develops investigator, regulatory, operations, guidelines and training manuals

Prepares for and attends project launch meetings

Prepares for and attends client meetings; provides follow up with client regarding any study issues as requested by Project Manager

Assists in the preparation and development of materials for the Investigators’ Meeting; attends Investigators’ Meeting and presents assigned topics; serves as the primary clinical representative to investigative site research staff

Attends and participates in internal and external training sessions

Contributes to Business Development by attending meetings with potential sponsors; contributes time and cost estimates (and/or reviews draft proposals for feasibility) for CTM-related activities

Provides financial management for the CTM portion of assigned projects as delegated by Project Manager and assists the PM by providing monthly updates on CTM's progress and performance with the project

Oversees scope of study tasks in order to identify any change and support change order process, if required

Assists with investigation grant payments as required

Monitors the preparation and timely completion of all regulatory filing packages and monitoring trip reports and reviews them for appropriate content

In conjunction with the Project Manager or Project Director, or as delegated, provides study-specific training to CTM personnel

Performs additional duties and assignments as requested

May perform direct Project tasks, such as site monitoring, if needed, and on a routine basis based on project expectations and/or status (i.e., query resolution/database clean time, non-compliant sites, high-enrolling sites, etc.)

Participate in accompanied/quality monitoring assessment visits

Provide performance feedback on CRAs for annual appraisals

Participate in departmental initiatives aimed at improving process and efficiency

Must be available to perform up to 33% overnight business travel, as required

Valid driver’s license

Required Skills

Required Experience

Demonstrated good management and mentoring skills

Disciplined work approach with the ability to function independently, take initiative and effectively problems solve issues

Customer service oriented both internally and externally with strong organizational, interpersonal and communication skills

Fluent written and verbal English language skills

Good computer skills including MS Word, Excel, PowerPoint, MS Outlook

Ability to work independently as well as part of a project team

Able to handle and prioritize multiple assignments in a fast-paced work environment

Good presentations skills are required

Knowledge of medical terminology, clinical pharmacology and pathophysiology is required

Proficient Regulatory Document review for IRB/IEC submissions

Demonstrated good working knowledge of the drug development process, Good Clinical Practices, International Committee on Harmonization Guidelines, Federal and European Regulations pertaining to clinical research investigations, as applicable

Bachelors’ degree (BS, BA, or RN equivalent) required; biological- or science-related field preferred

Experience with an minimum of three (3) therapeutic areas required

Minimum of three (3) years of clinical monitoring experience, two of which as a Senior CRA

Minimum of three (3) years experience with all phases of clinical trials

Minimum of three (3) years of clinical experience in the pharmaceutical, biotechnology, device or CRO industry or equivalent is required

Working knowledge of ICH-GCP/ISO14155 and relevant SOPs as required

Working knowledge of FDA, European Regulatory and EC procedures as applicable

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