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clinical trial manager resume example with 9+ years of experience

Jessica Claire
  • , , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
  • Home: (555) 432-1000
  • Cell:
  • resumesample@example.com
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Professional Summary

Experienced Clinical Trial Manager in study phases I, II, and III that encompasses working as a CRC, CRA and CTM. Experienced and detail-oriented professional in the performance and coordination or clinical trial operations.

Skills
  • 9-plus years’ 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
  • Innate passion to drive for results and keeping customer focus as the forefront
  • Proficient in Microsoft office.
  • Excellent interpersonal skills.
Work History
Clinical Trial Manager, 12/2019 to Current
Achilles Therapeutics, , Dedham, MA


  • 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 sets expectations for clinical team of CRAs and CTAs.
  • Address all CRA and site questions and documenting via the Frequently Asked Question (FAQ) log as appropriate.
  • Oversaw, supported, and track 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.
  • Collaborative with PM, CRAs and QA to develop any Corrective and Preventive Action Plan (CAPA) and ensure implementation and timely closure.
  • Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits.
  • Led internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs
  • Address all CRA and site questions and documenting via the Frequently Asked Question (FAQ) log as appropriate.
  • Oversaw, supported, and track 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.
  • 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 or managed clinical data review of patient profiles, data listings and summary tables, including query generation.
  • Reviewed site visit reports and ensures monitoring (i.e., scheduling and scope) is executed per monitoring plan.
  • Supported PM management of clinical vendors (e.g., labs, IP, patient diary, home health care).
Senior Clinical Research Associate , 03/2017 to 11/2019
Ockham, , Dedham, MA

• 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 current regulatory documentation for assigned sites according to Essential Regulatory Document Guidelines and/or regulatory project plan.

• Maintained all areas of cover as assigned (site & study level) to audit readiness standards and supported preparation for audit and required follow up actions.

• 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).

• Provided training or mentorship to more junior-level CRAs while also performing training and sign off visits for junior CRA staff, as assigned

•Routinely assured compliance with local regulations, Code of Federal Regulations (CFR) / International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor

• Critically evaluated adequacy of investigator sites (qualifications, facilities, equipment and performance). Successfully plans and conducts study initiation visits for investigator sites.

Clinical Research Associate II, 01/2015 to 02/2017
Drug Information Association Inc, , Dedham, MA

• Performed onsite drug (IP) accountability and reconciliation and verified drug storage met protocol and SOP requirements.

• Performed continuous reviews of Investigator’s Trial File to assure quality of the documentation files, completion and compliance with company SOPs, GCP and ICH Guidelines while on site.

• Responsible for ensuring 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 manner.

• Ensured Serious Adverse Event (SAE) reporting according to project specifications, reviewed SAE information, resolved queries and assisted sites in completion of SAE reports.

• Maintained close relationship with clinical investigators to improve protocol compliance,
improved serious adverse event reporting, met timelines by closely working with clinical sites

Clinical Research Associate, 08/2012 to 12/2014
Arthrex, Inc., , Dedham, MA


  • Maintained close relationship with clinical investigators to improve protocol compliance, improved serious adverse event reporting, met timelines by closely working with clinical sites
  • 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.
  • Participated in cross-functional clinical team(s) in the planning and execution of clinical trials in compliance with good clinical practices (GCP), department procedures and regulatory requirements.
  • Reviewed case report forms for completeness, accuracy, and legibility and performed source document verification.
  • Collaborated with other members within Clinical Trial Management (CTM) and with various vendor team members to ensure synergy and coordinated response to study issues.
  • Ensured and identified non-compliance issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, analyzing study metrics, and general study data review.
  • 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.
  • Supported selection of suppliers, execution and negotiation of agreements, and provide oversight of supplier work to ensure tasks are performed to scope and budget.
Education
Bachelor of Arts: Business Administration, Expected in to Hesser College - Manchester, NH,
GPA:

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Resume Overview

School Attended

  • Hesser College

Job Titles Held:

  • Clinical Trial Manager
  • Senior Clinical Research Associate
  • Clinical Research Associate II
  • Clinical Research Associate

Degrees

  • Bachelor of Arts

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