associate director study manager resume example

• Led clinical trial teams in operational planning, feasibility, and execution of Phase III clinical studies; facilitated clinical trial team meetings with focus on continuous improvement to foster collaboration; managed resources and timelines associated with study start-up, execution, and filing ensuring timely completion of milestones; collaborated closely with functional areas team members to work through financial and operational challenges; ensured delivery of all key study plans for start-up; led team in troubleshooting and ensuring proper integration of vendor data; provided input in eCRF development; organized and participated in face-to-face and virtual Investigator Meetings; mapped out database lock timelines and ensured team alignment; coordinated and ensured timely completion of mitigation plans in support of filing database lock; developed, implemented, and executed timelines for overall survival sweeps; established plans with vendors for transfers to support resolving issues and ensuring on time delivery for data base lock; led team in creation and completion of Deep Dive presentation; planned and executed clinical study report appendices deliverables in support of filing and company scorecard objective; facilitated and contributed to lessons learned for study database lock; coordinated and contributed in creation of inspection support team storyboards: participated in and contributed to process improvement project for Investigator Meetings coordinating efforts between trial team and various internal and external contributors; mentored 2 study managers on clinical study report appendices, coordinating investigator, filing activity, and inspection support team processes; acted as co-lead eTMF SME for Oncology; contributed eTMF health check details to operational review presentation template; facilitated and presented eTMF subject matter topics at Oncology Indication and Program Meetings; significantly contributed to updates of eTMF job aid; co-led group of 8 Oncology electronic master file SMEs; served as Oncology newsletter SME content coordinator.

• Led clinical trial team in operational planning and execution of Phase III clinical study; provided operational input in development and management of study timelines; developed detailed plans and prioritize tasks within plan to achieve project goals; managed resources and timelines associated with study start-up and implementation activities; proactively identified potential risks and developed/implemented mitigations; prepared and presented study status update reports; evaluated feasibility responses and determined allocation of sites and subjects based on that feedback; managed vendor set-up, management/oversight, and payments; major contributor to data management deliverables; collaborated with Global Clinical Supply team and Ancillary Supplies Management groups to plan and coordinate investigational medicinal product and other study ancillary supply needs; developed important study documents in support of trial execution such as pharmacy manual and AE guidance; worked with documentation specialist in development of site investigator binders; worked closely with regulatory in support of clinical trial application development and regulatory submissions; served as eTMF SME for Oncology

• Served as lead Study Start-up Specialist; provided key input in process and procedure development for new sponsor engagement; mentored and trained other Study Start-up Specialists; acted as knowledge expert in start-up process and requirements; liaised and collaborated with site managers.

• Supported 3 Merck Oncology trials simultaneously; coordinated clinical trial execution focusing on site ready, enrollment deliverables, and maintenance; created and maintained all Trial Team documents including agendas, communication plans, charters, team rosters, lines of communication, FAQs, ADI (Actions, Decisions, Issues) and Risk logs; responsible for maintaining Team Site for each study; served as main point of contact for all Team Site related issues; created and maintained Project Schedule; assisted in maintaining study timelines and meeting deliverables; ensured timely and accurate documentation and communication of study progress and issues; generated required reports within organizational guidelines including Trial Status Reports; reviewed Master Site User List and communicated changes to IVRS vendor; created and maintained site lists for all study vendors; created and posted all study announcements for field staff and sites; maintained web portal for field staff and sites; provided input on CRF, CRF guidelines, and other study related documents to ensure accuracy; resolved and escalated issues to project team; ensured compliance with protocol requirements; partnered with ancillary supplies coordinator in delivery of supplies; worked with document specialist in creation of trial binder and ensuring timely distribution to sites; updated and ensured CTMS was accurate at all levels; served as point of contact for country operations managers; back-up contact for CRAs, vendor, and functional team members; partnered with clinical supplies coordinator in supplies ordering and delivery; assisted in development of project plans and timelines; conducted meetings with country operations managers; reviewed investigator feasibility questionnaire responses and identified sites for study participation; evaluated processes for efficiency and quality and made recommendations for improvements; established performance metrics for project progress and evaluated performance against these standards; mentored other Clinical Trial Specialists.

• Drove site level study-start-up timelines and activities utilizing tools such as Project Scheduler and Trial Status Reports; elevated critical issues impacting site ready and first patient enrolled to clinical trial team and performed risk management activities; posted and maintained trial team documents; created and maintained trial team communication plan documentation; created trial team meeting agendas; maintained and distributed ADI logs; contributed in Monitoring Plan development and maintenance; served as point of contact for country clinical project managers; managed routing of documents requiring Merck signatures; lead entry of trial level information into CTMS in support of functional area activities such as ancillary supplies and financial planning and output; performed weekly logic checks of CTMS data; assisted with resolution of country level issues raised by ancillary supplies management group; provided protocol specific changes to finance department in support of site budget development; met with finance department representatives regularly to ensure timely budget/contract negotiations with sites; coordinated and facilitated site training and initiation visits; posted and maintained study start-up documentation for sites and monitors; created tools to support site recruitment efforts; reviewed regulatory documents to facilitate initiation; assisted sites in completion of IRB submission documentation; developed and distributed site binder materials; assisted vendor management with development of vendor specifications; participated in design and review of IVRS User Requirement Specifications; reviewed and provided input on study procedures manual and protocol amendments; communicated Merck user and site user information to study vendors; contributed to eCRF specifications and guideline development; interfaced with country operations clinical project managers and trial team members to ensure trial conduct according to company SOPs, applicable guidelines and local regulations; mentored other Trial Specialists on procedures, job role specific training, and systems in therapy area.

• Functioned as Trial Manager for Phase II Oncology Trial; planned and lead Study Team meetings; managed trial level timelines to ensure on time task completion and entry into CTMS; proactively identified and elevated critical study issues; assessed and communicated changes in timelines; developed and implemented contingency plans with other study team members as timelines shifted; maintained and evaluated enrollment tracking to identify enrollment issues; created and maintained company required project management tools; lead and created requests for vendor selection; performed vendor oversight; reviewed and confirmed that financial obligations were met by vendors and sites; served point of contact for global field monitoring personnel concerning protocol specific issues and study start up processes; wrote and maintained monitoring plan and other important trial level study conduct documentation; planned and conducted bimonthly meetings with monitors to communicate study status, solicit feedback and foster teamwork to meet timelines, and address study-related issues; tracked clinical supply inventory; coordinated and performed study SAE reconciliation; planned and executed cohort cleaning plan to soft lock subjects in preparation for database lock; performed data listing review; ensured data entry and query resolution; submitted and tracked change requests to eCRF; tracked and reported LPLV status to study team and field staff; assisted with preparing responses to audit queries and inspections in collaboration with audit response coordinator; developed and maintained tracking of site level study tasks; conducted monitor training; assisted monitors with site training; created study tools to increase enrollment; ensured timely completion of site initiation and start up activities by overseeing and performing execution of relevant documentation in support of protocol; assessed site timelines for IRB, budget, and contract processes to determine timeframe for initiation; reviewed regulatory documents to facilitate initiation.

• Main point of contact for global field monitoring personnel concerning protocol specific issues, site selection and start up processes; responsible for timely completion of site initiation start up activities by ensuring proper execution of relevant documentation in support of protocol; resolved issues with potential sites during site selection process; supported study manager in managing study team; proactively identified and elevated critical study issues; performed vendor oversight; aided in data listing development; aided in organizing and presented at study Investigator Meeting; created site feasibility questionnaire; participated in site selection and feasibility; developed study lab manual; aided in development of eCRF and database process; evaluated site feasibility questionnaires and reassessed those sites once pre-study visits were conducted; assessed site timelines for IRB, budget, and contract processes to help determine timeframe for initiation; reviewed regulatory documents to facilitate initiation; assisted sites in completion of IRB submission documentation; participated in Outside Services Committee in review of preferred and prospective vendors; trained new field monitors and clinical project specialists in document quality review and trial initiation approval processes; provided input on new document quality review process to SOP Committee.

Responsible for ensuring quality of site regulatory documents to support initiation and study conduct; liaised with regulatory department to obtain site initiation and drug shipment approvals; provided updates on enrollment and site initiation status for bimonthly senior management meetings; responsible for projecting clinical supply needs for both domestic and international sites; participated in co-monitoring visits; interacted with clinical supplies department to ensure timely release of clinical supplies; worked with company’s foreign clinical supplies group and country operations monitors to ensure all necessary import license and other important documents were in place; processed drug requests; tracked drug kits in order to enable resupply; liaised with vendor regarding drug shipments and personnel updates; troubleshooted issues with Interactive Voice Response System (IVRS); researched and organized list of potential investigators for 3 new studies; obtained secrecy agreements and site selection questionnaires; tracked all aspects of site selection process; assisted in preparation for advisory board meeting to develop new studies; provided feedback regarding existing Document Quality Review (DQR) process and support for DQR training and understanding of DQR process; aided in preparation for and present at Investigator’s Meeting; supported EMEA request, aided in submission to Japanese health authority.

• Performed quality reviews of regulatory documents in preparation for site initiations and on ongoing basis; reviewed informed consents prior to and after submission to IRBs; worked with regulatory department to obtain approvals for site initiations and drug shipments; created tracking for regulatory documents; contacted sites directly about issues with regulatory and financial documents; fielded inquiries from Country Operations monitors regarding international sites; processed drug requests; tracked drug kits in order to enable resupply; liaised with vendor regarding drug shipments and personnel updates; interacted with legal department regarding consent form and contract language; tracked scans for external professional review as part of pilot for central scan review; assisted in preparation and modification of protocol amendment; modified consent form template according to amendment specifications; involved in development of new process for Document Quality Review; participated in development of RFP for Trusted Third Party Repositories (TTPR); provided support for FDA and foreign submissions.

• Supervised all clinical trials performed at research center; aided in selection of new studies based on research center patient population and resources; Liaised with internal departments to establish use of hospital resources for various studies; conducted weekly staff meetings to review study and enrollment status; assisted in management of large, multi-center, simulated primary prevention trial for Alzheimer’s Disease; resolved queries from sites nationally regarding participant inclusion/exclusion criteria and proper procedures; liaised between sites and Project Director regarding exceptions to inclusion and other queries; participated in monthly conference calls with Project Director and clinical monitors to discuss enrollment status at investigative sites, resolved site issues and addressed other matters pertinent to study; provided feedback to sites and addressed any procedural changes or clarified procedures; ensured adherence to study protocol at all levels.

• Served as Manager for clinical trials division; managed 8 clinical trials concurrently and 14 trials overall; assisted in development and execution of action plan to comply with HIPAA regulations; administered and maintained phase II, III, and IV clinical trials; obtained and maintained IRB approvals for all protocols; reported serious adverse events (SAEs) and adverse events (AEs) to IRB; maintained SAE and AE log and process reports; prepared and maintained regulatory documentation and correspondence; modified sponsor provided consent forms; established internal standards of practice for each study; created source documentation; responsible for patient recruitment, tracking, and follow-up; devised ways of increasing enrollment by organizing and participating in weekly recruitment meetings; responsible for maintenance, dispensation, and destruction of study medication; served as liaison between grants office and pharmaceutical companies; reviewed and critiqued all study contracts; projected and maintained budget information for clinical trials; attended Investigator meetings; participated in site selection and monitoring visits; assisted in data clean-up; certified CDR rater; aided in psychometrics and other protocol-based questionnaires; trained in blood-borne pathogens and infectious substance shipping requirements; supervised staff of 3.

• Responsible for daily operation of research clinic specializing in aging and dementia; recruited new patients and coordinated diagnostic evaluations of patients for Alzheimer diagnosis; maintained patient files and consent form documents; revised all essential study documents as needed; monitored storage and upkeep of research samples; ensured that patient charts received review by staff physicians and clinicians in timely manner to determine diagnosis; reorganized operations as needed to increase patient flow and to enable patient visits; aid in maintenance of research database; participated in monthly enrollment and scientific meetings; supervised staff composed of volunteers, students, and doctors in fast-paced research environment; administered manual and computerized neuropsychological assessments with normal to cognitively impaired elderly adults; assessed verbal and visual/spatial memory, language perception, psychomotor and gross motor function.

• Performed all administrative support necessary to Clinic Coordinator; maintained daily patient schedule; aided in maintenance of patient files and research database; fielded patient inquiries regarding study participation and billing; scheduled patient appointments; ensured that patient appointments took place in timely manner; coordinated patient appointments with off-site facilities; processed payments; aided in transport of research samples.