Clinical Project Manager
MRC Clinical Project Managers report to executive management and collaborate closely with trial team members to ensure effective development of plans, strategies and execution across multiple clinical development programs and/or clinical trials. Responsibilities include, but are not limited to:
• Management of all logistical and operational activities related to Phase I to IV clinical trials from study start-up through closeout, ensuring adherence to regulatory guidelines, relevant MRC SOPs, study timelines and inspection readiness.
• Develop, communicate and evaluate trial management plans to include trial team objectives, workflows and timelines.
• Coordinate and collaborate with data managers, statisticians and any other trial team entity such as central laboratories to ensure project timelines and milestones are met.
• Coordinate, manage and document all trial team meetings, to include preparation and maintenance of agendas and meeting minutes.
• Develop and/or provide input and review on study related documents such as clinical monitoring plans, clinical data management plans, protocols, informed consents, case report forms (electronic or paper), clinical study reports, statistical analysis plans, CRF completion guidelines, EDC training guides, site instructions for specimen collection, laboratory manuals, investigative site GCP and protocol training materials, investigator newsletters etc.
• Serve as the primary point of contact for trial Sponsor.
• Development of tools to provide weekly progress reports to the Sponsor and MRC management.
• Oversight and management of trial related third party vendors such as central labs, statisticians, and translation companies. Includes identifying potential risks, resolving issues, establishing vendor management plans and reviewing quality metrics.
• Coordinate and obtain required documentation for site qualification and selection.
• Developing systems/tools to track all aspects of the trial, including all study, investigator and institutional/ethical review board information, patient enrollment activity, and financial management.
• Providing oversight and management of all trial team members responsible for filing study records in the Trial Master File (TMF) to ensure compliance with required regulatory guidelines, GCP standards and MRC SOPs.
• Providing oversight, support and input to collect and maintain appropriate documentation for adverse event safety reporting and collaborating in the submission of safety reports to the FDA, IRBs/IECs and other applicable regulatory authorities.
• Development of recruitment strategies to increase patient enrollment.
• Developing tools for the provision, accountability and tracking of clinical trial materials such as Investigational Product (IP) and non-IP materials to investigative sites for the duration of the trial and ensuring site accountability records are maintained.
• Performing and/or overseeing site initiation, interim monitoring and close-out visits as needed to include training materials used during visits.
• Collaborating with MRC Data Management during electronic data capture configuration, validation and data cleaning.
• Coordinate the monitoring of all trials by managing MRC Clinical Research Associates (CRAs) to include the review of all monitoring reports for accuracy and timeliness and the review of protocol deviations and clinical data to ensure reliable quality data are delivered.
• Establishing and executing quality control procedures.
• Responsible for the financial management of the clinical trial including budget planning and tracking, resource allocation and preparation of quarterly reports. To include negotiation of site budgets within Sponsor guidelines and execution of Clinical Trial Agreements (as applicable to the duties delegated to MRC by the trial Sponsor).
• Training and coaching of CRAs in various aspects of trial management (trial budgets, IP and non-IP allocation etc.) that are relevant to the trial.
• Providing support and assistance to sites preparing for clinical audits and responding to audit findings conducted by internal quality management or external regulatory agencies.
• Accountable for ensuring all project deliverables meet the clients' expectations as well as MRC standards.
• Assist MRC management in any activity or duty deemed necessary for successful project implementation and coordination.
• Bachelor Degree (BA/BS) in health, life sciences or related field is required; Master or PhD is preferred.
• Minimum of 5 - 7 years' experience in drug/biologic/device development to include one year experience as Project Manager in clinical development.
• Advanced knowledge of ICH guidelines on Good Clinical Practice and FDA regulations. International clinical trial experience and knowledge of other country regulatory requirements is preferred.
• Advanced computer skills in Word, Excel and PowerPoint are required. Experience with document management applications, SAS and Electronic Data Capture is preferred.
• Excellent communication skills (oral and written) and interpersonal skills are required.
• Strong operational management with attention to detail is required.
• Willingness to travel (to include domestic and international travel) as required.
• Knowledgeable of preparation of regulatory submissions for FDA and other countries.
Morley Research Consortium has been committed to high performance standards for the past sixteen years. Coming from all areas of the biotech and medical device industry, MRC professionals are not only passionate about their work but have years of experience successfully managing all phases (I - IV post-market) of clinical trials in a wide variety of therapeutic areas. MRC's difference is in our people, knowledge, and results.
Thu, 13 Jul 2017 10:27:47 PDT