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Clinical Trial Manager (Consultant)

Company: Beacon Hill Staffing Group - Pharma
Location: Worcester
Posted on: May 17, 2018

Job Description:

JOB RESPONSIBILITIES: Support the lead Clinical Trial Manager in the planning, execution and control of one or more clinical trials. Create site questionnaires, review completed site questionnaires and qualification visit reports, and coordinate the site approval process. Coordinate with the cross-functional team to ensure site confidentiality agreements and clinical trial agreements are executed. Create study specific informed consent forms, and lead the review and approval process. Support investigators in fulfilling their obligations with regard to submission and maintenance of trial documents according to applicable local, regulatory and IRB/IEC requirements. Oversee the essential document collection process, including review and approval in support of drug shipment to study sites. Coordinate translation of selected study documents. Contribute to review and finalization of key study plans and site facing documents. Troubleshoot, advise and follow up trial progress with investigative site staff and clinical vendors. Monitor clinical vendors for quality of service. Manage subject screening/enrollment, data collection and query resolution and trial supplies at investigative sites. Manage distribution of study supplies to clinical sites Perform and/or oversee data entry into CTMS, project timeline, or other project management systems as needed. Assist with the preparation, coordination and documentation of the study team meetings. Prepare key reports and documents on progress of trial and quality issues/concerns for the project team in a timely manner. Address study site issues/concerns with the investigator and other study team members as needed, determine root cause, and independently offer corrective and preventative actions, documenting follow-up activities and outcomes Draft and coordinate approval of clinicaltrials.gov listings. Prepare site newsletters and other communications. Review clinical data listings and participate in data review processes. Train team members on project specific tasks as applicable. In-house monitoring of study site activities and data collection. Site management, which may include; pre-study visits, initiation visits, monitoring visits, telephone contacts and study close-out visits and/or visit report review. Monitoring visit activities include, but are not limited to: source document review; CRF review and data corrections; review of patient consent process; drug accountability; review of investigative site files; and Serious Adverse Event (SAE) reporting according to the protocol/project specifications Participate in company required and/or sponsored training programs and initiatives. Perform other duties as assigned. EDUCATION AND EXPERIENCE: Associate or BS/BA degree or equivalent (background in life sciences preferred) ACTM - Minimum 3+ years of clinical research experience Direct monitoring experience or equivalent in-house clinical trial and investigative site management experience Thorough knowledge of and demonstrated competency in clinical trial process Working knowledge of FDA regulations and ICH/GCP guidelines Proven ability to demonstrate strong decision making and problem solving skills Demonstrated ability to work independently in performing responsibilities Must be willing to travel (domestic and international 20%+)

Keywords: Beacon Hill Staffing Group - Pharma, Worcester, Clinical Trial Manager (Consultant), Professions, Worcester, Massachusetts

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