Experience

ERGOMED

• United Kingdom
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Clinical Trial Manager

  • Apr 2022 - Present

  •Direct communication with project allocated Monitors, and CTAs •Direct communication and collaboration with the Sponsor representative in projects where only operational management is contracted •Organizing and facilitating project team meetings (e.g. weekly calls with Monitors, CTAs), and ensuring meeting minutes are reviewed, approved and distributed to all concerned parties •Developing, reviewing and revision of project documents (e.g. monitoring plan, CRF completion guidelines, study specific operating manual, study specific forms etc.). •Review and verifying that all required documents are in good order for the first Investigational Medicinal Product release to the investigational site •Review of Monitors’ reports •Report all site issues (unable to resolve on CTM level) to PM/designee with action plan / propositions for discussions •Manage preparations for site specific audits, attending in-house project audits if required, analysis of received audit report, proposing, and overseeing completion of Corrective and Preventative Action Plan •Responsible for operational project management and act as the direct project line manager to allocated study monitors. •Ensure that project team members (monitors, CTAs) are trained in study specific procedures, protocols, requirements and SOP to perform their assignments' •Facilitate project team meetings and ensure meeting minutes are reviewed, approved, and distributed to all concerned parties •Develop, review, and revise of project documents such as monitoring plan, CRF completion guidelines, study specific operating manual, study specific forms. •Investigator identification and selection •Initiate corrective and preventative measures such as update of study guidance documents, performing retraining, performing co-monitoring Show less



Syneos Health

• United States
• Biotechnology Research
• 700 & Above Employee

• Clinical Trial Manager

  • Jun 2020 - Apr 2022

  •Acts as the primary point of contact at a country level for assigned studies and have operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities. •Collaborates with Project Manager for country protocol feasibility and site feasibility assessment. •Collaborates with other Study Team Members to select final site list. •Leads and coordinates local trial team activities in compliance with SOPs. •Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. •Participates in the optimization of local processes and mentoring activities for junior CTLs. •Ensures that all Adverse Events/Product Quality Complaints are reported within the required reporting timelines; prepares country specific informed consent in accordance with procedural document/templates; maintains and updates trial management systems. •Assists in negotiation of trial site contracts and budgets; forecasts and manages country/local trial budget to ensure accurate finance reporting. •Acts as subject matter expert for assigned protocols; develops strong therapeutic knowledge to support roles and responsibilities. •Actively leads and contributes to process improvement, training and mentoring of CTAs, Monitors and other CTLs. •Acts as primary local/country contact for a trial; establishes and maintains excellent working relationships with external (investigators, study trial coordinators and other site staff). •Maintains compliance with protocols covering patient care and clinical trial operations. •Participates in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets. •Collects data and followed research protocols, operations manuals and case report form requirements. •Manages quality assurance program, including on-site evaluations, internal audits and customer surveys. Show less



ICON plc

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Trial Manager

  • Mar 2016 - Jun 2020

  •Oversees and monitors the management of the clinical study, ensuring it is conducted in accordance with the approved study plans.•Supports the study team to execute the clinical study in accordance with the clinical development plan/strategy and timelines.•Manages and/or assists in the oversight of CRO activities and other clinical vendors to ensure the quality meets company and regulatory requirements.•Leads/assists in oversight of the identification and selection of investigator sites.•Assists and/or participates in planning and conduct of investigator's meetings.•Provides input and coordinates the delivery of clinical trial supplies in collaboration with clinical supply team.•Collaborates with the cross functional team on selection and potentially management of clinical vendors.•Monitors the status of clinical data collection of assigned clinical studies.•Performs periodic visits to sites and/or CROs to assess progress of studies/protocol compliance.•Reviews clinical monitoring reports and correspondence related to monitoring visits.•Ensures effective communication between ICON and the Clinical Sponsor.•Develops and reviews study plans including the clinical review of Case Report Forms (electronic as applicable), data review plan, and other data management documents and corresponding completion guidelines.•Generates or assists in critically evaluating proposals, contracts, and change orders from CROs and other vendors. Show less

• Senior Clinical Research Associate

  • Jan 2013 - Mar 2016

  •Provided study status updates to team members and project.•Management, including interaction to resolve site issues and facilitate project timelines.•Served as primary contact for assigned research sites.•Verified that the investigator, staff, and site facilities remain adequate throughout the trial period.•Responsible for the scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and closeout visits according to the Monitoring Plan.•Ensured research sites conduct studies according to protocol requirements and applicable regulations and guidelines.•Reconciled site regulatory binder assuring collection and completeness of regulatory documents.•Collected and ensured completeness of all essential regulatory documentation from sites from study start-up through closeout.•Verified that written informed consent was obtained before each subject's participate in the trial.•Verified that the investigator is enrolling only eligible subjects.•Performed verification of source documents against Case Report Form/Electronic Data Capture entries to assure accurate and complete data.•Ensured that corrections are appropriately documented.•Performed Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.•Ensured all types of adverse events are reported and tracked per regulatory requirements and the Monitoring Plan.•Ensured that sites have sufficient project specific supplies.•Managed and motivate sites to meet study goals.•Communicated deviations from the protocol, SOPs, and/or GCP, to the investigator, and project management team and take appropriate action to prevent recurrence.•Delivered high quality written trip reports, confirmation and follow-up letters within timelines of SOPs and monitoring plans.•Participated in site audits, as requested. Show less



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Research Associate II

  • Feb 2011 - Jan 2013

  •Provided study status updates to team members and project management, including interaction to resolve site issues and facilitate project timelines.•Served as primary contact for assigned research sites.•Verified that the investigator, staff, and site facilities remain adequate throughout the trial period.•Responsible for the scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and closeout visits according to the Monitoring Plan.•Performed site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance. Visits may be performed on-site or remotely.•Ensured accurate data reporting via review of site source documents and medical records.•Performed investigational product accountability as per the protocol and Study Monitoring Plan.•Evaluated execution of study protocol at the site level. Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team.•Reconciled site regulatory binder assuring collection and completeness of regulatory documents.•Collected and ensures completeness of all essential regulatory documentation from sites from study start-up through closeout.•Verified that written informed consent was obtained before each subject's particular in the trial.•Performed verification of source documents against Case Report Form/Electronic Data Capture entries to assure accurate and complete data.•Delivered high quality written trip reports, confirmation and follow-up letters within timelines of SOPs and monitoring plans.•Collected and reviewed regulatory documents received from clinical sites to ensure all required documents are obtained, completed and in compliance with ICH-GCP and local regulations.•Assisted with preparation, review and submission of all relevant regulatory documents to the Show less

• Clinical Research Associate I

  • Feb 2009 - Feb 2011

  •Responsible for performing and coordinating all aspects of the clinical monitoring and site management process for your assigned sites in accordance with ICH GCP, local regulations and IQVIA SOPs. Served as primary contact for assigned research sites.•Verified that the investigator, staff, and site facilities remain adequate throughout the trial period.•Conducted site visits to assess protocol and regulatory compliance as well as managing required documentation to ensure that data will pass international quality assurance audits.•Ensured research sites conduct studies according to protocol requirements and applicable regulations and guidelines.•Performed site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance. Visits may be performed on-site or remotely.•Reviewed completion of proper informed consent procedures.•Ensured accurate data reporting via review of site source documents and medical records.•Interpreted data to identify protocol deviations and risks to subject safety/data integrity.•Generated queries and manage resolutions with site personnel.•Performed investigational product accountability as per the protocol and Study Monitoring Plan.•Evaluated execution of study protocol at the site level. Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team.•Obtained, reviewed, and processed essential regulatory and administrative documents. Conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance.•Verified that written informed consent was obtained before each subject's particular in the trial.•Verified that the investigator is enrolling only eligible subjects. Show less