Senior Clinical Trial Manager (DG)
Job Location: Parsippany, NJ (see all jobs in NJ)
Work Type: Remote
Date Posted: 2022-03-09
Remote (based out of NJ)
The Clinical Trial Manager is responsible for the execution and delivery of all aspects of assigned clinical trials. The CTM participates in the design of clinical trial synopses and clinical trial protocols. The CTM understands the therapeutic context of the clinical program and is able to discuss hypotheses with investigators and other hospital staff. This role assists with execution of contracts with vendors, development and maintenance of budgets and is responsible for the timeliness and quality of outcomes from investigative sites. The CTM leads the multidisciplinary team composed of clinical research, pharmacovigilance, regulatory, business development, and commercial staff as well as investigative site staff and consultants and CROs to achieve departmental goals.
ESSENTIAL DUTIES & RESPONSIBILITIES:
Leads the cross functional Clinical Study Team. Participates in the formulation of Clinical Study Concept and Clinical Study Planning documentation. Assists in protocol feasibility analysis and protocol development. Leads the site qualification and initiation process, including scheduling monitoring activities with site personnel. Manages (or delegates) the study start-up activities including site selection and review of regulatory documents and ensures site is qualified for the study. Plans, schedules, and communicates with internal and external resources required to conduct the studies (supplies, services). Presents at and participates in Investigator Meetings, other study trainings and meetings as required. As necessary, can independently perform monitoring visits, including site qualification, study site initiation, routine monitoring and study site closure visits. Establishes and maintains regular contact with investigators, vendors and study sites to ensure GCP/ICH/protocol compliance, and compliance with SOPs. Ensures site compliance with study protocols. GCP/ICH, applicable regulations prior, during and following visits. Works with site personnel and study team to prevent, address and resolve issues. Maintains ICH-GCP documentation for trial sites as stipulated. Manages (or delegates) the shipment of study material to and from study sites. Communicates project-specific information to/from trial sites and documents communication with study site/ team and escalates issues to team in a timely manner. Ensures the reporting of high-quality data and timely query resolution. Reviews adverse event reports and ensures the site is reporting the events appropriately and in a timely manner. Troubleshoots problems related to clinical studies and interacts with the Quality System customer feedback and corrective action systems as appropriate. Supports compliance with legal and regulatory requirements of FDA, European Union, and other requirements. Participates with Clinical staff in identifying and preparing sites to be audited by internal or external auditors. Tracks internal and external audits of investigational sites and analyzes outcomes. Assists Clinical management with regulatory submissions, and other reports as required. Assists with the development and/or maintenance of Clinical infrastructure such as the drafting or reviewing SOP's and Work Instructions. Provides mentoring and direction to junior staff regarding protocols, site management and the execution of all the duties listed above. Participates in data analysis, interpretation and report review.
Direct supervisory responsibility of a Clinical Trial Associate. Provides mentoring and direction of junior staff.
The Clinical Trial Manager leads and works together with the Clinical Study Team, including Medical, Biostatistics, Data Management, Regulatory Affairs, Medical Writing, Supply Operations, and Project Management to assure the timely and effective design, execution, safety monitoring, and reporting of Phase I-IV clinical studies.
EDUCATION AND EXPERIENCE:
Bachelor’s degree in a health, biological sciences or research related field from accredited college or university, or equivalent experience. Minimum of six (6) years clinical research experience in the U.S. biotech/pharmaceutical industry, including 2 years of independent management of clinical studies. Demonstrated knowledge of FDA regulations and Good Clinical Practice (GCP) Guidelines as they relate to protection of human subjects. Demonstrated knowledge of Electronic Data Capture systems. Excellent written and oral English communications skills. Proficient in MSOffice including, Outlook, Word, Excel, Access, PowerPoint and MSProject. Ability to travel up to 25% of the time including some weekends.
KNOWLEDGE, SKILLS, AND ABILITIES:
Demonstrated working knowledge of cGCP, ICH and other relevant clinical development and FDA regulations and processes. Excellent written and oral English communication and presentation skills. Ability to successfully interact and communicate with variety of professionals at all levels of the organizations with whom s/he interacts. Demonstrated knowledge of and commitment to abiding by ethical standards in research. Excellent analytical, organizational and time management skills. Ability to work effectively on a team in an entrepreneurial environment.
Please contact Darren Gutowski at firstname.lastname@example.org
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