clinical trial manager resume example with 8+ years of experience
Jessica
Claire
resumesample@example.com
(555) 432-1000,
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Professional Summary
Resourceful Clinical Trial Manager with several years of expertise in organizing business operations, financial oversight and resource management to achieve smooth flow and project operations. Monitors projects by adhering to production schedule and budget, managing production team, identifying problems and providing targeted solutions.
Skills
8-plus yearsā experience in the research industry with onsite monitoring activities, in Oncology, CNS, Respiratory, Rare Diseases, Infectious diseases and Medical Device.
Thorough knowledge of clinical development processes and conduct of clinical studies.
Awareness of global regulatory and pharmacovigilance environments.
Experience in coordinating collaboration with investigative centers, clinical staff, and CROs.
Experience in site management from phase I -III
Excellent working knowledge of GCP/ICH guidelines and FDA regulations.
Excellent communication and written skills.
Strong working knowledge of medical/scientific terminologies.
Experience working with EDC (AGMednet, iMednet Rave and inform) and CTMS (SimpleTrials, IMPACT and Medidata Rave) systems.
Excellent ability to effectively communicate with physicians, study coordinators and other site staffs.
Excellent collaboration with team members and constantly striving for teamwork
Education
Texas Southern UniversityHouston, TX, Expected in ā āBachelor of Science:Health Studies - GPA:
Collaborated with PM on monthly invoicing and variance management of clinical budget
Supported in planning and conducting Investigator Meetings
Generated potential site list from key stakeholders and drive site feasibility process
Identified potential risks to the enrollment targets based on feasibility analysis and siteās contracted commitment
Developed and finalized the country recruitment/retention strategy
Developed timely and effective communication and good working relationships with investigative sites and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures
Led internal clinical team meetings and set expectations for clinical team of CRAs and CTAs
Addressed all CRA and site questions and documented via the Frequently Asked Question (FAQ) log as appropriate
Reviewed and/or approved IP release packages
Oversaw, supported and tracked all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable
Supported the legal department and/or site contracts group with site budget and contract negotiations
Developed clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
Generated and utilized metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate
Responsible for oversight of eTMF implementation and management
Collaborated with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and ensure implementation and timely closure
Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits
Worked closely with PM and CTM Management for project-specific resourcing issues
Escalated pertinent CRA performance and site compliance issues when necessary
Collaborated with data management and CRAs to ensure data quality and compliance with data cleaning timelines
Performed and managed clinical data review of patient profiles, data listings and summary tables, including query generation
Philips - Senior Clinical Research Associate , , Houston, United States11/2016 - 08/2017
Critically evaluated adequacy of investigator sites (qualifications, facilities, equipment, and performance). Successfully plans and conducts study initiation visits for investigator sites.
100 percent completion and submission of monitoring visit reports in accordance with SOP/Work Instructions or Sponsor requirements as agreed in the scope of work. Also, routinely maintains awareness of key study performance indicators for delegated sits.
Supports subject recruitment and retention strategies.
Ensured all assigned sites are trained and compliant with requirements of the study protocol, informed consent process, data collection requirements/data collection tools.
Verified that the process of obtaining informed consent has been adequately performed and documented for each subject.
Maintained site performance metrics and implements action plans for sites not meeting expectations with minimal guidance.
Maintained all areas of cover as assigned (site & study level) to audit readiness standards and supports preparation for audit and required follow up actions.
Routinely demonstrated sufficient time management to achieve assigned required deliverables: consistent on time expense reports, timecard submissions, trip report submissions/finalization, monitoring visits frequency as per Statement of Work (SoW), Clinical Monitoring Plan (CMP). Follows standard process for documentation of site contacts (visits, phone, email etc.).
Performed device inventory, reconciliation, storage, and security. Experience in verifying that the device has been deployed and administered to subjects according to the protocol.
Routinely reviewed the Investigator Site File (ISF) for accuracy, timeliness, and completeness. Reconciles contents of the ISF with that of the trial master file (TMF).
Maintained effective, accurate, and timely communication with the site staff and project team. Top notch participation in global conference calls and meetings to review progress of ongoing clinical trials.
Merck - Clinical Research Associate I & II , , Houston, TX08/2014 - 11/2016
Maintained close relationship with clinical investigators to improve protocol compliance, improved serious adverse event reporting, met timelines by closely working with clinical sites
Improved critical clinical data flow through extra-mandated delegation between clinic and data management crew
Responsible for performing study activities regarding the implementation and monitoring of clinical trials to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations, and SOPs.
Monitored recruitment and data quality while onsite and remotely through EDC systems/communication with sites.
Performed onsite drug (IP) accountability and reconciliation and verified drug storage met protocol and SOP requirements.
Performed continuous reviews of Investigatorās Trial File to assure quality of the documentation files, completion, and compliance with company SOPs, GCP and ICH Guidelines while on site.
Responsible to ensure that the mandatory trial entries were made in all requisite study systems including clinical trial management systems, IVRS, TMF, etc.
Collaborated with other members within Clinical Trial Management (CTM) and with various vendor team members to ensure synergy and coordinated response to study issues.
Acted as the primary liaison for assigned study sites while onsite to convey project information, answer questions and address study issues in accordance with the monitoring plan.
Performed source document verification, retrieved case report forms (CRFs) and performed query resolution in a timely.
Ensured Serious Adverse Event (SAE) reporting according to project specifications, reviewed SAE information, resolved queries and assisted sites in completion of SAE reports.
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