Clinical Operations Consultant- Trial Management

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.

Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.

The Clinical Trial Manager (Contractor) will manage all operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring GCPs and relevant SOPs are met. The incumbent will manage study-related service providers and serve as the primary point of contact for contracted CROs, study staff and contract labs as appropriate; identifying potential risks and resolving issues with CROs; and ensuring study feasibility is performed as appropriate. The incumbant may also be called upon to help mentor or guide less-senior staff.

• Partners with Sourcing department in RFP process, identifies scope of work, study contracting needs, CRO selection process, provides input into vendor management plan, reviews quality metrics and shares lessons learned.
• Manages and executes vendor kick off meetings, face-to-face meetings, team training, and trial webex as required for trial execution.
• Reviews and oversees the development, review and operational aspects of site investigator grant and grant payment in accordance with sponsor process requirements.
• Tracks and obtains necessary approvals related to vendor contract change orders.
• Provides operational review and content to the study protocol and coordinates completion of QC review of the protocol.
• Leads and/or supports clinical operational team meetings in support of the respective clinical trial including: drafting agenda, collect minutes, filing minutes in the TMF, tracking action items, providing ongoing status of trial enrollment and timelines, outlining vendor related deliverables, communicating risk/issues, and managing input from other internal and external partners.
• Coordinates and manages investigator meetings including development of the agenda, management of slide development and review, coordination of meeting planner activities, and presenting at investigator meeting.
• Conducts thorough review of key specification documents related to the trial and oversees/participates in the UAT for IWR, EDC, eDiary and other systems.
• Provides content for study related systems and portals.
• Serves as the clinical operations representative on team meetings held by other functions and provides necessary input into key process related documents.
• Conducts monitoring/co-monitoring of investigative sites as applicable.
• Approves study invoices related to trial vendors.
• Provides input into and/or develops study related materials such as Clinical Monitoring Plans, Data Management Plans, eCRF forms and completion guidelines, protocols, patient informed consent drafts, site instructions for specimen collections, and approval for site receipt of study drug.
• Performs and/or coordinates designees in processes related to designees’ monitoring report review, protocol deviations and data listings for sponsored studies to ensure reliable quality data are delivered.
• Coordinates the CROs on site selection, IRB submissions, site initiation and close-out planning.
• Tracks patient recruitment and progress to study timelines; supports site receipt of safety reporting; maintains and reports metrics for clinical study and CRO delivery performance.
• Performs and/or oversees site monitoring visits for clinical trials as needed including and not limited to ensuring clinical supplies accountability records are maintained.
• Provides oversight to staff maintaining clinical trial master files to ensure their compliance with required regulatory and GCP quality standards and consistency with company SOPs.
• Provides input and support for trial site maintenance of appropriate documentation for adverse event safety monitoring.
• Supports QA and regulatory agency activities related to trial related audits pertaining to clinical executions (e.g. sites, TMF, etc.) including coordination of responses/corrective actions related to audit findings 

• Bachelors degree in health or biologic science (BS/BA/BScN); masters-level degree is preferred.
• Minimum of 5 years of clinical study management experience in the biopharmaceutical industry, including a minimum of 2 years as a clinical study lead/project manager; global clinical trial experience is highly preferred.
• Experience in management of contracted resources/CROs, site monitoring and clinical quality compliance.
• Strong CRO oversight and operational management skills with proven attention to detail.
• Advanced knowledge of Good Clinical Practices and current knowledge of FDA regulations for IND clinical trials; international clinical trial experience and knowledge of other country regulatory requirements is preferred.
• Effective oral/written communication and interpersonal skills.
• Advanced computer skills including proficiency in MS Office.
• Willingness to travel up to 20% including domestic and international travel.
• Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate.