Senior Clinical Trial Manager

Parexel FSP has an exciting opportunity for a Sr. CTM. This candidate is responsible for :Manages all operational aspects for implementation of one or more clinical trials and all activities from study start-up through database lock, ensuring Good Clinical Practices (GCP) and relevant SOPs are metManages study-related service providers and serves 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 appropriateStudy Start UpParticipates in CRO selection process, validates clinical scope of work, supports auxiliary service outsourcing, provides input into vendor management plan, reviews quality metrics, and shares lessons learned as requiredManages and executes vendor kick off meetings, face-to-face meetings, team training, and trial WebEx as required for trial executionReviews and oversees the development, review, and operational aspects of site investigator grants and grant payment in accordance with sponsor process requirementsProvides operational review and content to the study protocol and coordinates completion of QC review of the protocolCoordinates and manages investigator meetings including development of the agenda, management of slide development and review, coordination of meeting planner activities, and presenting at investigator meetingCoordinates the CROs on site selection, IRB submissions, site initiation and close-out planningClinical Trial Operational DeliveryLeads 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 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 partnersConducts thorough review of key specification documents related to the trial and oversees/participates in User Acceptance Testing (UAT) for Interactive Response Technology (IRT), Electronic Data Capture (EDC), eDiary and other systemsProvides content for study related systems and portalsServes as the clinical operations representative on team meetings held by other functions and provides necessary input into key process related documentsApproves study invoices related to trial vendorsTracks and obtains necessary approvals related to vendor contract change ordersProvides 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 drugPerforms 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 deliveredTracks patient recruitment and progress 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 visits for clinical trials as neededProvides oversight to staff maintaining clinical trial master files to ensure their compliance with required regulatory and GCP quality standards and consistency with company SOPsProvides input and support for trial site maintenance of appropriate documentation for adverse event safety monitoringSupports Quality Assurance 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 findingsProvides ongoing assessment of subject enrollment and discontinuations to ensure accurate forecasting for financial planningPerforms other duties as assignedCompliance with Parexel StandardsComplies with required training curriculumCompletes timesheets accurately as requiredSubmits expense reports as requiredUpdates CV as requiredMaintains a working knowledge of and complies with Parexel processes,ICH-GCPs and other applicable requirementsSkills:Effective oral/written communication and interpersonal skillsAdvanced computer skills including proficiency in MS OfficeDemonstrated ability to communicate and coordinate with internal and external team membersAble to proactively identify project challenges/risks and outline appropriate actions to Clinical Operations Team Lead, (COT-L)Country level cultural awareness and strong interpersonal skillsKeen problem-solving skillsDetail oriented and possesses technical expertise (e.g., spreadsheets, metrics, and data flow managementWillingness to travel as required for key company meetingsProficiency in written and spoken EnglishKnowledge and Experience :Minimum of 5 years of demonstrated direct responsibility for clinical study leadership in the biopharmaceutical industryGlobal clinical trial experience is strongly preferredDemonstrated ability to independently lead a clinical study from startup activities through data base lock and regulatory submission(s)Ability to see the "big picture" and the role of a study within the overall programAdvanced experience in management of contracted resources/CROs, site monitoring and clinical quality complianceStrong CRO oversight and operational management skills with proven attention to detail requiredAdvanced knowledge of Good Clinical Practices and current knowledge of FDA regulations for IND clinical trialsApplies knowledge of GCP/regulatory requirements to all aspects of study preparation and oversightDocumented experience with data safety monitoring board (DSMB) activitiesEducation :Bachelor's degree (health or biologic science preferred); masters-level degree a plus#LI-KW1#LI-REMOTEEEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.