Sponsor company clinical trials manager

Lead clinical trials for Merck as contractor through Execupharm. Redacted submission documents for FDA/EMA posting.

Clinical lead for global studies.

• Design clinical development plans and protocols to meet corporate and regulatory obligations to advance the development of various products, new dosage forms and formulations, changes in product labeling, and to support product claims.• Collaborate with academic thought leaders and KOLs, and maintaining excellent working relationships with technical consultants. • Develop study designs and negotiate costs to ensure compliance with budgetary appropriations. • Ensure that all aspects of clinical research protocols are properly planned and executed according to regulatory requirements (e.g., FDA, EMEA) and guidelines (e.g., ICH, GCP) and provide recommendations regarding the operational feasibility of selected study designs.• Develop budgets for clinical research studies and ensure compliance with approved budgets in coordination with Global Project Managers and Project Leads.• Identify, evaluate, and manage outsourcing for assigned clinical trials.• Implement and adhere to appropriate scientific standards with regards to all aspects of clinical research projects.• Work with RBP Business, Clinical, and Regulatory teams to prepare development strategies leading to product labeling that fully exploits competitive advantages and enables advantageous promotional positioning.• Ensure that CRO, consultant, and other vendor activities are in keeping with study protocol requirements, health authority regulations, and SOP, GCP, and ICH guidelines.• Oversee recruitment of clinical sites/investigators; plan and lead study kick-off meetings; lead clinical development sessions of project team meetings.• Coordinate the Clinical activity (dossier development and review, presentation) for regulatory authority meetings (FDA/EMA).

Clinical Research Consultant for Phase III vaccine study

Oversee clinical activities in global study. Manage clinical operations and quality aspects of allocated studies to ensure compliance with ICH GCP. Serve as the primary clinical operations contact for the CRO. Review site feasibility and qualification visit reports to ensure appropriate sites selected for the protocol. Organize Investigator Meetings and conduct training at these meetings. Review data listings and create manual queries. Review clinical activity timelines and metrics and provide regular status updates. Anticipate obstacles and implement solutions to achieve assigned goals through regular project review using tracking & management tools. Manage vendors and associated budgets and timelines. Contribute to development of Protocols, Investigator Brochures, Clinical Study Reports, Ethics Committee responses, & MOH responses. Communicate regularly with all other related departments to ensure timelines, resources, interactions and quality are maintained.

Coordinate and manage CRAs within allocated project. Responsible for clinical resource management, assignment, & delegation. Supervise and mentor CRAs; conduct CRA performance appraisals and provide input for merit adjustments and bonuses. Review monitoring visit reports and ensure finalization is within contractual timeline. Manage CRF collection and query resolution process and assist as needed. Serve as the primary clinical operations contact for the Project Manager and CRAs. Prepare and monitor clinical activity timelines and metrics. Provide regular status updates for client reports. Ensure regular project review, using tracking & management tools, implementing appropriate recovery actions to ensure project timelines are met. Communicate regularly with all other related departments to ensure timelines, resources, interactions and quality are maintained.

Coordinated the implementation of clinical studies at investigational sites and managed five contract CRAs assigned to those sites. Assured compliance with protocol and overall clinical objectives, federal regulations, and company policies and procedures through monitoring report review/approval and Site/CRA contact. Reviewed Data Listings and created manual queries. Created documents for internal and external use including but not limited to: internal memoranda, investigator/site correspondence, trip reports, telephone contact reports, notes-to-file. Created and managed tracking systems for and organized transportation of serum samples from holding facility to Nabi. Reconciled CRF database and holding facility database to ensure all serum samples had been shipped from sites. Coordinated collection, accuracy, and transfer of subject test data from central reader to Nabi and reconciled central reader and CRF database.

Performed Pre-Study, Initiation, Interim Monitoring, and Close-Out visits. Used PPD and sponsor SOPs, used sponsor’s Rapid-Data Flow process, and assisted in creating monitoring tools for the team. Took a lead role in training team members, creating monitoring tools for the team, performing data listings review, and creating queries. Used Query Direct, PPD’s query management system and performed secondary CRF and data listings review.

Performed secondary CRF and data listings review. Performed Pre-Study, Initiation, and Interim Monitoring visits. Assisted in the development of case report forms, source documents, and other regulatory forms. Developed systems to track financial payments to the sites. Performed data entry and data management for Phase I-IV clinical trials in ClinTrials 4.2.

Acted as the Lead Coordinator for 10 Phase III-IV clinical trials in various psychiatry and neurology indications. Managed advertising, patient recruitment, screening, cognitive evaluations, and psychiatric scales. Set up and maintained Excel-based programs to track patient visits and company reimbursement.