Senior Clinical Trial Manager

Parexel•Southport, NC

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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

Requirements

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
Minimum of 5 years of demonstrated direct responsibility for clinical study leadership in the biopharmaceutical industry
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
Bachelor’s degree (health or biologic science preferred)

Nice To Haves

Global clinical trial experience is strongly preferred
masters-level degree a plus

Responsibilities

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
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
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
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