Senior Clinical Trial Manager

reputed company FSP has an exciting opportunity for a Sr. CTM. This candidate is responsible for : • Manages reputed company operational aspects for implementation of one or more reputed company and reputed company activities from study start-up through database lock, ensuring Good Clinical Practices (GCP) and relevant SOPs are met • Manages study-reputed company service providers and serves as the primary reputed company 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 Study Start Up • Participates in CRO selection process, validates clinical scope of work, supports auxiliary service outsourcing, provides input into vendor management plan, reviews reputed company metrics, and shares lessons learned as required • Manages and executes vendor reputed company 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 grants and grant payment in accordance with sponsor process requirements • Provides operational review and content to the study protocol and coordinates completion of QC review of the protocol • 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 • Coordinates the CROs on site selection, IRB submissions, site initiation and reputed company-out planning Clinical Trial Operational Delivery • Leads and/or supports clinical operational team meetings in support of the respective clinical trial including drafting agenda, collecting minutes, filing minutes in the TMF, tracking reputed company items, providing ongoing status of trial enrollment and timelines, outlining vendor reputed company deliverables, communicating risk/issues, and managing input from other reputed company partners • Conducts thorough review of key specification documents reputed company to the trial and oversees/participates in User Acceptance Testing (UAT) for Interactive Response Technology (IRT), Electronic Data Capture (reputed company), eDiary and other systems • Provides content for study reputed company systems and portals • Serves as the clinical operations representative on team meetings held by other functions and provides necessary input into key process reputed company documents • Approves study invoices reputed company to trial vendors • Tracks and obtains necessary approvals reputed company to vendor contract change orders • Provides input into and/or develops study reputed company 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 reputed company to designees’ monitoring report review, protocol deviations and data listings for sponsored studies to ensure reliable reputed company data are delivered • Tracks patient recruitment and reputed company to study timelines; supports site receipt of safety reporting; maintains and reports metrics for clinical study and CRO delivery performance. • Conducts and/or oversees site monitoring reputed company for reputed company as needed • Provides reputed company to staff maintaining clinical trial master files to ensure their compliance with required regulatory and GCP reputed company standards and consistency with company SOPs • Provides input and support for trial site maintenance of appropriate documentation for adverse event safety monitoring • Supports reputed company Assurance and regulatory agency activities reputed company to trial reputed company audits pertaining to clinical executions (e.g., sites, TMF, etc.) including coordination of responses/corrective actions reputed company to audit findings • Provides ongoing assessment of subject enrollment and discontinuations to ensure accurate forecasting for financial planning • Performs other duties as assigned Compliance with reputed company Standards • Complies with required training curriculum • Completes timesheets accurately as required • Submits expense reports as required • Updates CV as required • Maintains a working knowledge of and complies with reputed company processes, ICH-GCPs and other applicable requirements Skills: • Effective oral/written communication and interpersonal skills • Advanced computer skills including proficiency in MS Office • Demonstrated ability to communicate and coordinate with reputed company team members • reputed company to proactively identify project challenges/risks and outline appropriate actions to Clinical Operations Team reputed company, (COT-L) • Country level cultural awareness and strong interpersonal skills • Keen problem-solving skills • Detail oriented and possesses technical expertise (e.g., spreadsheets, metrics, and data reputed company management • Willingness to travel as required for key company meetings • Proficiency in written and spoken English Knowledge and Experience: • Minimum of 5 years of demonstrated reputed company responsibility for clinical study leadership in the biopharmaceutical industry • Global clinical trial experience is strongly preferred • Demonstrated ability to independently reputed company a clinical study from startup activities through data reputed company lock and regulatory submission(s) • Ability to see the “big picture” and the role of a study reputed company the overall program • Advanced experience in management of contracted resources/CROs, site monitoring and clinical reputed company compliance • Strong CRO reputed company and operational management skills with proven attention to detail required • Advanced knowledge of Good Clinical Practices and reputed company knowledge of FDA regulations for IND reputed company • Applies knowledge of GCP/regulatory requirements to reputed company aspects of study preparation and reputed company • Documented experience with data safety monitoring reputed company (DSMB) activities Education: • Bachelor’s degree (health or biologic science preferred); masters-level degree a plus #LI-KW1 #LI-REMOTE Apply To This Job