Associate Clinical Trial Manager

Celldex Therapeutics, Inc.

Clinical

February 5, 2014

Overview:

The Assistant Clinical Trial Manager plays an important role in our organization by overseeing and monitoring clinical trials. This individual ensures that the clinical studies are conducted per established policies, procedures, regulations, and Good Clinical Practices (GCP) and delivered with high quality, on time and within planned budget. The Assistant Clinical Trial Manager will bring his or her high degree of competence in clinical research and prior exposure to all aspects of clinical research to one or more domestic clinical trials. The first few months will require travel to the Branford, CT office.

 Clinical Trial Oversight:

•    Comprehensive oversight of operational aspects of assigned clinical trials. The assigned trials would generally be less complex and domestic trials. Responsibilities would include the preparation and/or review/approval of study-related documents (e.g., Laboratory Manual, Monitoring Plan, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, CRF Completion Guidelines, etc.)

•    Proactively monitor study status and develop and implement a risk mitigation strategy as needed to ensure the study progresses according to plan

•    Ensure compliance with relevant regulations and guidelines by maintaining regular contact with external vendors and internal or external CRAs. Complete sponsors’ review of monitoring reports. Identify potential study issues and recommend/implement solutions.

•    Organize and manage internal team meetings, investigator meetings and other trial-specific meetings

•    Actively participate in data review and cleaning for the trial (extent dependent on level of services outsourced)

•    Maintain a working knowledge of all relevant functional area SOPs and ensure adherence in the conduct of work-related activities

•    Oversee set up and maintenance of the Trial Master File. Review of essential regulatory documents supporting study conduct.

 Monitoring:

•    Maintain contact with and act as a liaison and resource for investigational sites

•    Perform monitoring visits including site qualification, initiation, interim monitoring and closeouts

•    Visit report and site communication preparation

•    Prepare for and participate in sponsor and FDA audits

•    Reviews site data remotely (if possible) in preparation for study visits and as a part of overall study data cleaning

•    Performs other additional job related duties as required.

 Required Skills:

•    Excellent oral and written communications.

•    Strong computer skills including knowledge of Microsoft Excel, Word, and Outlook and EDC

•    Ability to work within established timelines, in a fast paced environment

•    Excellent organizational and priority management skills

•    Sound knowledge of medical terminology

•    Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact

 

Education/Experience:

•    BS/BA degree in science

•    2 – 3 years of prior experience

•    Experience as a lead CRA and prior experience managing clinical trials for or within the biotech or pharmaceutical industry, including CRO/vendor management and clinical site monitoring,

•    Prior oncology experience preferred

•    Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required

•    Ability to travel 40% - 75% depending on project needs

 

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