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Clinical Study Manager Resume Samples
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0-5 years of experience
Directed or personally executed study conduct and close-out activities for 22 site, US phase II trial as key member of small internal team and consultants for young biotechnology company.
- Identified, oversaw and collaborated with various vendors that delivered site management and monitoring, central image reading, recruitment and public relations for phase III trial to ensure compliance to protocol and GCP guidelines.
- Compiled and communicated various study metric and summary reports to senior management and company board of directors.
- Key contributor or developer of all study documents including protocol, ICD template, CRFs and data collection tools, CRO oversight plan, site training materials.
- Oversaw site management and monitoring vendor to complete feasibility and selection and start-up of over 90 study sites for US based phase III trial.
- Developed study level recruitment materials and reviewed all site specific materials to align with trial and company messaging.
0-5 years of experience
Reviewed protocols and advised Clinical Research Scientist regarding logistics involved in the conduct of the study for pain management trials in 15 centers within US.
- Developed informed consent, case report forms with completion guidelines, source documents and monitoring plan for reference ensuring study trial procedures and processes were followed.
- Supported regional CRAs in successfully monitoring clinical trials by reviewing and approving site reports, co-monitoring, conducting weekly meetings, resolving individual and site issues and maintaining training records.
- Conducted study start- up for two pain management trials to include recruitment of 30 investigational sites for each trial.
- Coordinated two investigator meetings in 8-month period.
0-5 years of experience
Managed up to 4 clinical studies simultaneously. Accountable for Study Start up, Conduct, and Study Closure. Organized and presented Investigator meetings. Participated in Global studies as an USA affiliate.
- Provided leadership for clinical research studies, ensuring timelines and deliverables met or exceeded standards.
- Assisted with protocol and amendment review, reducing corrections.
- Conducted 2 phase 1 investigator meetings. Participated in 1 phase IV investigator meeting, which included vendors and global personnel.
- Developed good rapport with PIs and SCs and ensured 24-hour response time. Kept enrollment open during plant closures, allowing for continuous communication. Delivered exceptional customer service, especially with phase 1 studies.
- Selected to pilot 4 new programs and processes in the U.S. Identified obstacles, contributed to solutions, shared findings for global rollout and revisited issues as needed.
- Managed financials for each study including: budget negotiations, forecasting, assumptions, invoices and reconciliation. Selected vendor when applicable. Managed CROs in phase IV studies.
- Streamlined supported studies by closing 49 out of 84, decreasing costs and resources. Received overpayments from 4 sites.
- Orchestrated an Oncology department site selection database. Team members entered the site's area of expertise, past study information and future study interests. This information decreased study start up timelines
- Received Employee Recognition Award for contributions in 2008 and 2012: 2008 Team Work Recognition Award. Worked on Nephrology Studies. Helped DM, MD and Clinical Operations resolve issues, allowing for DBL 1 day early.
0-5 years of experience
Managed daily operational activities associated with 19 Phase 1-4 clinical studies, including study start-up, interim conduct and closeout activities
- Ensured high performance and efficiency of the study team by providing ongoing study-specific training of the Regional CRAs and other study staff
- Interacted with and built professional and collaborative relationships with all study personnel (investigators, study coordinators, pharmacists, etc)
- Developed timelines for site initiation, interim monitoring, and closeout visits. Monitored progress and worked with Regional Managers to ensure adherence to timelines
0-5 years of experience
Manages Clinical Operations, including 3 direct reports. Oversees clinical trials from development to closeout, with a focus on surgical and wound care applications of a Section 361 tissue product. Responsible for providing guidance to all sites on study administration. Maintains regulatory filing and reporting. Creates and manages all study documents (protocol, ICF, contracts) and data tools including CRFs and study database. Manager of clinical trials for industry-sponsored trials reporting directly to Chief Medical Officer.
- Promoted to department manager in 2015.
- Organizes and oversees internal Clinical Events Committee
- Grew clinical department from running 3 studies at 3 sites to 10 studies at 50+ sites in 2 years, wrote and managed all clinical documents for these studies
- Builds departmental infrastructure with the goal of FDA compliance, including writing SOPs
0-5 years of experience
Acted as the primary contact between [company name] and pharmaceutical company representatives in order to conduct all aspects of a successful Phase I clinical trial (end to end project management).
- Obtained study protocol from the pharmaceutical company and broke it down to its key aspects.
- Partnered with departments across the company to implement study protocol key aspects internally.
- Ensured conduct of the clinical trial was 100% accurate and in compliance with strict Food and Drug Administration guidelines.
- Collaborated with physicians and nurses in order to make sound decisions quickly regarding aspects of patient health.
0-5 years of experience
Managed and executed clinical trials in oral care, microbiology and dermatology for major pharmaceutical companies according to both company and client driven protocols, ensuring compliance to both GCP and ICH-GCP guidelines.
- Directly supervised clinical study coordinators and laboratory technicians implementing clinical trials, microbiology validation tests, and conducted site initiation meetings with clients and monitors.
- Implemented clinical SOPs, GCPs, as well as design of GLP guidelines.
- Proficient in protocol design and writing as well as design of source documents and case report forms.
- Experienced in preparation and review of clinical summary reports and final reports.
- Excellent knowledge of the IRB process and regulatory compliance issues.
- Assisted business development in creation of proposals for clients and in formulation of study budgets streamlined to maximize profitability.
0-5 years of experience
Wrote clinical portion of Product Development Plan; presented to CEO and Senior VPs
- Wrote Phase III Dyslipidemia protocols, participated in discussion of protocol design with FDA, updated Investigators Brochures, Safety reports, managed conduct of study, selected sites, prepared and negotiated budgets, CRFs, drug supply, informed consents/HIPAA, created study aids, planned Investigators' Meeting
- Coordinated Electronic Data Capture for studies
- Hired, trained and managed 7 direct reports
- Oversaw 22 regional monitors
0-5 years of experience
Managed a clinical research study to identify acute cases of [company name] infection in high risk populations in Abuja, Nigeria
- Prepared and maintained all study protocols and Institutional Review Board (IRB) regulatory documents
- Trained study staff on all aspects of the [company name] research protocol including community recruitment for [company name] education and testing, [company name] counseling and testing and enrollment of [company name] positive patients in PEPFAR [company name] treatment programs
- Monitored and evaluated all study site activities such as study enrollment, data collection, data entry, data management, [company name] counseling, serology and PCR testing
- Supervised all laboratory activities in [company name] serology and molecular testing (Polymerase Chain Reaction (PCR))
- Prepared study progress reports, documented implementation barriers and made recommendations for all study areas
- Analyzed study data for abstracts, manuscripts and grants
0-5 years of experience
Clinical study manager role with operational responsibilities for early phase studies in the area of hematological oncology and the management of several gout studies in early development. Held a supportive role in the development program, ensured that study timelines were achieved, worked with data monitoring committees and was responsible for all financial aspects related to the ongoing studies.
- Operational oversight and management of CROs and other selected vendors.
- Creation of yearly project budgets and ensured completion of studies within budget.
- Reviewed and approved all pertinent study related materials.
- Created RFPs, reviewed SOWs, and participated in vendor selection activities.
- Facilitated the clinical study report process from shell development through publishing.
- Participated in the development of recruitment strategies to ensure milestones were met.
- Recommended and successfully transitioned a study from a CRO back in-house for significant operational cost savings.
0-5 years of experience
Study manager and Sr. CRA for antiviral and antibiotic clinical programs (Phase I-III) which included large multi-site trials.
- Assisted Clinical Project Director with all aspects of program.
- Implemented research program by monitoring and coordinating clinical trial sites.
- Responsible for final protocol and case report form development.
- Coordinated activities of support services.
- Supervised and trained Clinical Research Assistants and Technical Assistants.
- Prepared and supervised preparation of reports for submission to management and FDA.
0-5 years of experience
Clinical Study Team Lead for protocols Phase III/IV in therapeutic areas Hepatitis C/Gastroenterology and Rheumatology
- Management of sponsored protocols, including protocol development, CRO selection, data management, SAE reconciliation, and site management according GCP/ICH/FDA guidelines
- Accountable for delivering studies on time and within budget
- Calculated, forecasted and managed drug supply across studies to ensure adequate drug supplies
- Created, managed and maintained study timelines and finances to ensure timely delivery within budget
- Reviewed and provided recommendations on protocol design, protocol amendments and informed consent forms to ensure operational consistency, development of CRFs and study related documents
- Evaluated, selected and managed CROs and vendors, including budget/invoice tracking, to ensure timely delivery against scope of work
- Maintained departmental databases (CFAR/BEN/AIMS/CTMS)
- Responsible for contract processes and internal/external communications
- Interviewed department new hires
0-5 years of experience
A very large publicly held worldwide pharmaceutical company with diverse products and annual sales in excess of three billion dollars. Reported to VP of Clinical Operations.
- Responsible for the organization, implementation, and project management of two major Phase III global clinical studies [Retinal Vein Occlusion (RVO) and Diabetic Macular Edema (DME)] that would effectively support the launch of key ophthalmic products.
- Developed and managed project specifications, assumptions, timelines, budgets, payment schedules, and resources for both studies with sole responsibility and signatory authority for approval of site selection, investigator selection, laboratory selection, and drug shipments.
- Directly managed five Senior Clinical Research Associates (CRAs) and lead a team of 20 CRAs and six CPAs; designed and implemented plans for staff training, development, and motivation and conducted staff performance evaluations.
- Assured compliance with all FDA, CLIA, and other applicable regulations including FDA mandated Good Clinical Practices (GCP) and Good Laboratory Practices (GLP).
- Created, forecasted, and operated detailed project budgets and reduced the budget forecasting error margin from 8.0% to 1.4% by improving analytical methods for tracking expenses.
- Increased the rate of patient enrollment by implementing a new patient enrollment recruitment strategy that utilized an informatics approach that factored in scientific aspects of patient recruitment, market research, outcomes metrics, and benchmark statistics; developed study implementation material for recruited patients including informed consents, brochures, and scripts for videos.
- Evaluated and implemented study vendor outsourcing contracts including preparation of Requests for Proposal (RFP) in conjunction with the legal/contract negotiation department.
- Participated with Clinical Operations as a core member of the strategic communication team, providing input into preparation of formal strategies to resolve financial/operational issues and ensure effective and timely communication of key messages related to clinical studies.
0-5 years of experience
Responsible for management of the Clinical Study Management Team
- Served as the primary contact for all assigned projects while providing managerial oversight and ensuring regulatory compliance for all trials conducted at the Neptune facility
- Managed escalated client issues, concerns and requests to ensure absolute client satisfaction
- Performed protocol review for adherence to project standards
- Represented the Study Management Team during management meetings
- Hired, fired, trained, disciplined, and evaluated employee performance.
6-10 years of experience
Project manager of numerous international and domestic clinical studies. Authored clinical study reports, abstracts.
- Participated in the publication plan including manuscript development for anti-infective products.
- Frequent presenter at company's GCP workshop and Investigator Meetings, end of study meetings.
- Supervised up to 7 CRA consultants and managed large CROs for Zithromax
- Developed innovative recruitment campaign "Refocus on Respiratory" for investigator and monitors
- Led CRA training for Latin American, Asian and European to review GCP and protocol training.
0-5 years of experience
Managed specimen collection pre-clinical studies for healthy controls, ovarian cancer, sickle cell anemia, multiple myeloma, and psoriasis
- Recruited investigator sites and negotiate site budgets
- Prepared regulatory documents for IRB submission
- Conducted study initiation visits and start-up teleconferences
- Managed sites during multiple ongoing genomic specimen collections
- Participated in study planning meetings
- Developed study documents
- Developed and manage tracking tools
- Established key investigative networks: OB/Gyn oncology, hematology, urology, oncology, and dermatology
0-5 years of experience
- Managed the daily operational activities associated with the conduct of clinical studies monitored by Abbott in accordance with the country specific regulations.
- Followed GCP, ICH, and applicable SOPS
- Managed the daily operations of Phase 1-4 clinical studies, including study start-interim conduct, and closeout activities,
- Coordinated team meetings with the regional CRAs
- Collaborated with internal functional groups to managed study issues and support the milestone achievements. Tracked study parameters.
- Negotiated and managed investigator budgets.
- Identified quality issues/CAPA's until completion.
0-5 years of experience
- Managed a clinical research study to identify acute cases of HIV infection in high risk populations in Abuja, Nigeria
- Prepared and maintained all study protocols and Institutional Review Board (IRB) regulatory documents
- Trained study staff on all aspects of the HIV research protocol including community recruitment for HIV education and testing, HIV counseling and testing and enrollment of HIV positive patients in PEPFAR HIV treatment programs
- Monitored and evaluated all study site activities such as study enrollment, data collection, data entry, data management, HIV counseling, serology and PCR testing
- Supervised all laboratory activities in HIV serology and molecular testing (Polymerase Chain Reaction (PCR))
- Prepared study progress reports, documented implementation barriers and made recommendations for all study areas
- Analyzed study data for abstracts, manuscripts and grants
0-5 years of experience
Assisted Program Directors; Managed associates, managers, post-doctoral fellows, and interns
- Developed and managed multi-million dollar study budgets as part of the POA process
- Co-developed protocol with Medical Director and Statistician
- Liaised with Statistics, Data Management, Project Management, Legal, Finance, Marketing. Medical and Vendors to achieve study milestones: Interim analyses, final analyses, database locks, clinical study reports, publications and submissions to regulatory agencies
- Therapeutic Experience in Phase IIIB & IV: Oncology, Endocrinology, Virology, Transplant, Infectious Disease
0-5 years of experience
Responsible for overseeing the site's clinical study portfolio and ensure that studies are being executed as per the sponsor's protocol and guidelines.
- Maintain relationship with the sponsor and serve as the first point of contact for new projects.
- Allocate resources for the execution of clinical study projects.
- Ensure that all site staff are trained and properly equipped for their roles.
- Troubleshoot and resolve issues at the site as required.
- Participate in site feasibility assessments and answer sponsor questions with regards to site capabilities.
- Work with the Principal Investigator to evaluate the opportunities and challenges presented by each potential project.
0-5 years of experience
- Managed the conduct of two Phase III studies of a compound indicated for benign prostatic hyperplasia (BPH) including oversight of a CRO and central clinical laboratory.
- Project level management responsibilities for two clinical trial assistants
- Tracked and routinely communicated study progress to the Director of Clinical Operations
0-5 years of experience
- Overall responsibility for the scientific and operational conduct of the studies allocated, under the auspices of a preceptor.
- Ensured that all studies were conducted in accordance with Federal, state and protocol requirements, standard operating procedures, Good Clinical Practice (GCP), and Covance standards of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) as appropriate.
- Primary client contact and ensured that client requirements were met as well as the safety and integrity of the study participants was maintained.
0-5 years of experience
Responsible for management of BE/BA & Phase 1 studies, included setting project milestones, meeting timelines, troubleshooting and communicating with the study team.
- Assisted in the clinical process improvements within the Phase 1 and Bioequivalence department.
- Prepare and review study documentation in accordance with company SOP and research Protocol.
- Conduct receipt, inventory, handling, dispensing, and dosing of clinical trial material.
- Liaise with Business Development, Analytical Laboratory, Statistical Laboratory, Recruitment, and Sponsor to meet project goals.
- Write clinical protocols and Informed Consent Documents.
- Create Protocol-specific Source Documents.
- Participate in staff hiring and training sessions.
0-5 years of experience
Prepare on-study source documents, schedules and educate others on procedures/timelines for studies
- Ensure that all observations and procedures specified in the protocol are carried out and documented appropriately, ensuring compliance with protocol
- Multi-tasking to handle multiple studies at one time with no errors
- Professionally manage and interact with sponsors/vendors/monitors and Clinical Trial Managers
- Work daily with Microsoft Word, Excel and Outlook
0-5 years of experience
Managed studies in a fast-paced Phase I unit
- Proficient in venipuncture, IV insertion, subcutaneous/intramuscular injections, vital signs and electrocardiograms
- Coordinated renal studies including accompanying patients to dialysis appointments, coordinating with nephrologists, and capturing study data
- Obtained medical history from participants in order to ensure that study entry criteria was met
- Served as the primary point of contact for clients for all study-related issues
- Monitored participant safety and compliance, including coordination of medical consultation and treatment
- Ensured that all studies were carried out in strict accordance with the relevant protocols, Standard Operating Procedures and the specified standard of the Good Clinical Practices
- Facilitated the coordination of timelines, goals, and objectives for all study activities
- Reviewed participant eligibility information to determine if protocol criteria was met
0-5 years of experience
Maintain knowledge of multiple study protocol, including all protocol specific requirements
- Maintain knowledge of therapeutic areas through familiarity with clinical and scientific literature and participation in professional activities
- Conducts evaluation, initiation, routine monitoring and close out visits
- Monitoring and tracking all documentations regarding adverse events, drug supply, and sponsor and IRB queries.
- Conducts site training on protocol specific requirements
- Case Report Form (CRF) review according to CRF completion guidelines and protocol specific instructions
- Ensures compliance to GCP/ICH Guidelines, applicable regulations and Standard Operating Procedures (SOPs)
0-5 years of experience
- Develop project cross-functional, integrated study plan to study start up and validate and manage to the overall study plan provided by the CRO.
- Contribute to operational delivery aspects of the protocol and take a document review & coordination role for the protocol and amendments; and act as the project manager of the clinical study team to liaise and coordinate with internal stakeholders to ensure cross functional integration and delivery of items per the study plan.
- Responsible for management of CRO(s) performance to ensure adherence to scope of work within timelines and budget at a task level.
- Provide oversight of the CRO to ensure compliance with [company name]’s quality measures.
- Oversight of the transmittal of trial and site level documents to the [company name] Document Control Center (DCC) in support of the Trial master File (TMF).
- Support department in codifying existing knowledge and best practices.
0-5 years of experience
Reviews, edits, and approves CRA site reports and FU letters for DVT and cardiology trial.
- Coordinates monitoring activities on numerous projects and tracks all the visits.
- Participates in the training of junior clinical staff.
- Schedules the regional CRA's clinical visits (i.e., SIV, RMV, COV).
- Manages the regional CRAs and conducts weekly teleconferences.
- Serves on clinical committees and attends all management meetings.
- Writes the weekly newsletter and works with vendors.
0-5 years of experience
- Responsible for regional study management of two Phase III Ophthalmology clinical trials involving 50 sites in North and South America.
- Oversight of 1 CRO and 8 vendors
- Management and oversight of 4 in-house CRA's
- Manage and monitor study expenses to meet budget forecast
- Responds to Research Compliance site audit and vendor reports
6-10 years of experience
Management of multi-center trials, for both IDE and and post-marketed products.
- Preparation of study protocols, site contracts and trial budgets.
- Author clinical sections of annual and final reports for submission to FDA.
- Device tracking and accountability for Investigational Product with regard to hip
