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 met
• Manages 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 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 quality metrics, and shares lessons learned as required
• 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 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 close-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 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
• Conducts 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 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
• Approves study invoices related to trial vendors
• Tracks and obtains necessary approvals related to vendor contract change orders
• 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
• 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.
• Conducts and/or oversees site monitoring visits for clinical trials as needed
• 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 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 findings
• Provides ongoing assessment of subject enrollment and discontinuations to ensure accurate forecasting for financial planning
• Performs other duties as assigned
Compliance with Parexel 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 Parexel 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 internal and external team members
• Able to proactively identify project challenges/risks and outline appropriate actions to Clinical Operations Team Lead, (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 flow 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 direct responsibility for clinical study leadership in the biopharmaceutical industry
• Global clinical trial experience is strongly preferred
• Demonstrated 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 program
• Advanced 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 required
• Advanced knowledge of Good Clinical Practices and current knowledge of FDA regulations for IND clinical trials
• Applies knowledge of GCP/regulatory requirements to all aspects of study preparation and oversight
• Documented experience with data safety monitoring board (DSMB) activities
Education:
• Bachelor’s degree (health or biologic science preferred); masters-level degree a plus
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• 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 met
• Manages 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 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 quality metrics, and shares lessons learned as required
• 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 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 close-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 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
• Conducts 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 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
• Approves study invoices related to trial vendors
• Tracks and obtains necessary approvals related to vendor contract change orders
• 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
• 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.
• Conducts and/or oversees site monitoring visits for clinical trials as needed
• 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 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 findings
• Provides ongoing assessment of subject enrollment and discontinuations to ensure accurate forecasting for financial planning
• Performs other duties as assigned
Compliance with Parexel 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 Parexel 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 internal and external team members
• Able to proactively identify project challenges/risks and outline appropriate actions to Clinical Operations Team Lead, (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 flow 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 direct responsibility for clinical study leadership in the biopharmaceutical industry
• Global clinical trial experience is strongly preferred
• Demonstrated 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 program
• Advanced 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 required
• Advanced knowledge of Good Clinical Practices and current knowledge of FDA regulations for IND clinical trials
• Applies knowledge of GCP/regulatory requirements to all aspects of study preparation and oversight
• Documented experience with data safety monitoring board (DSMB) activities
Education:
• Bachelor’s degree (health or biologic science preferred); masters-level degree a plus
#LI-KW1
#LI-REMOTE
Apply tot his job
Apply To this Job