Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Summary

Take responsibility for coordinating the clinical monitoring activities, overseeing the CRO clinical /site management activities and co-monitoring the assigned international Ph 3 clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards of quality, timely delivery and within budget, in order to assist in the delivery of Clinical Development objectives and achieve clinical excellence. Coordinate the achievement of assigned clinical study deliverables within a matrix organization under the leadership of the Clinical Project Managers (CPM). Be a client representative at site and build relationship with our investigators.

Role: Senior CTM, Clinical Trial Manager, FSP Dedicated

Location: US, Remote- this candidate MUST be located on the East Coast, may also look at CST, but East is highly preferrable

Main Responsibilities/ Job Expectations

Ensure clinical activities coordination & oversightEnsure efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set-up (DM, reg, CMC, etc); ensure feasibility report are exhaustive,  Review site feasibility reports as per oversight plan , support the CPM in site selection, verify timely collection of essential study documents, such as regulatory and ethics committee documents for submission, and by controlling that all set up activities are performed prior to each site initiation, as per the oversight plan.Support and ensure that all specific Client/CRO EDC system tasks under the clinical responsibility are completed and achieved according to the defined timelines without jeopardising the start of a trial. Support the Clinical CRO in the training of the CRAs on all study specific operational activities and participate  in  the  organisation  and  preparation  of  the  monitor  and  investigator  meetings  in collaboration with the other study team members (Corporate and/or affiliates, CROs as appropriate) Assist the CPM/ study team in the evaluation of detailed timelines and establishment of clinical studies milestones for assigned projects, ensuring that they are performed to the most rigorous standards of quality and timely delivery.Prepare and/or assist in the production of all documents necessary to oversee the clinical activity implementation, monitoring and reporting in a professional, high quality and timely manner (such as monitoring oversight plan and clinCustomize site Key Risk/Performance Indicator template and follow these KRIs/KPIs at frequency agreed in the oversight planValidate the final clinical study documents (such as study manual, monitoring plan, prepared by the Clinical CRO.Review all/a sample of site visit reports as per the Oversight Monitoring Plan, ensuring timely and appropriate follow up of issues raised by monitors (Corporate & affiliates and/or CROs as appropriate).If applicable, provide support and guidance to Internal CRAs (Client Corporate & Affiliates with provision of some supervision in specific cases).Coordinate and manage the CRO relationship, assisting CRO CRAs/CTLs when and where necessary. Collaboration with the CPM in the RFP process and participation to BID defense meetingIf applicable to set up regular meeting with MSL (Medical Science Liaison) at LMA (Local Medical Affairs) who can support Clinical Operations at various steps (site qualification, site recruitContribute to the efficient operation of the TA Group and to transversal project cross- TAs and other departments within client (e.g. systems implementation, change management initiatives, continuous improvement initiativesEnsure the monitoring oversight of different activities entrustedCo-monitor clinical studies according to the oversight plan, ensuring adequate contact with investigator sites, identifying and solving issues in study progress, verifying data in-house or by conducting co- monitoring visits, in collaboration with other study team members, and following up as required with CROs/CRAs/investigator.Participate in  the  ongoing clinical  study  data  reviews  in  collaboration with  the  other  study  team members.Make appropriate and timely reporting in CTMS,  with regular checks for quality and accuracy.Ensure the agreed timelines for data collection (CRF/eCRF) and data clarifications/queries are met, sending information to data-management and monitoring CROs as appropriate.Ensure that study samples/assessments flow as required per protocol is well coordinated between the various stakeholders (CROs/Vendors/client departments) from site to the central facility/specialized lab. Participate in TMF quality check review regularly to ensure adequate completion during the study course with a final thorough review at the end of the trial prior to study archivingParticipate in the preparation and follow-up of any other study systems (such as IWRS/IMP forecasting/flow etc, as requiredMaintain and review key clinical documents required for Clinical Study Report (CSR), to ensure adequate quality (e.g. for CSR appendices publishing)As appropriate, participate in the preparation of study documents and perform site visits prior to audits /inspection and assist in audit follow-up /findings resolution.Be a client ambassador at site and create relationship with our InvestigatorsPerform various study related functions to ensure the execution of clinical studies such as: act as site CRA as directed by line manager act as back up of the CPM when requested

Complete all of the above activities within the framework and in compliance with client Global SOPs and other documentation in force within the client group.

Clinical activities (out of studies)Contribute/participate  on  SOP  update  and  review  training  material  created  by  Process  Training ManagementContribute to the efficient operation of the TA Group and to transversal project cross- TAs and other departments within client (e.g. systems implementation, change management initiatives, continuous improvement initiativesEHS ResponsibilitiesComply with applicable EHS regulations and procedures.Participate in the site's EHS performance by reporting risks, malfunctions or improvementsParticipate in mandatory EHS training

Knowledge, abilities and experience

Education / Certifications:Life science or medical graduate or other relevant qualifications.Minimum: CRA graduatedExperience:  Relevant experience of pharmaceutical drug development:This candidate MUST have experience as a Field CRA monitor(Independent) for at least 3 years (CROs or Pharma Industry)Therapeutic Indication: Oncology and/or Neuroscience Experience of minimum 1 year (ideally 2 years) of Lead CRA e.g. coordination of clinical activities/site management activities for the set up and running of international registrational studies (multiple sites/countries).Excellent Knowledge of Good Clinical Practice (GCP), ICH regulations.Experience in preparing clinical study documentation for study set up, maintenance and closingExperience in managing and developing relationships with Contract Research Organizations (CROs). Global studies (multiple countries/sites) experiencePrevious experience in the Therapeutic area of studies (Neuroscience, Oncology or radiopharmaceutical compound, etc.. )Please note: this candidate must be comfortable traveling 20-25% of the time to sites as well. Languages:  English: Strong intermediate level

Key Technical Competencies

Ability to work in a strong regulated environment within a quality management system (QMS) Advanced knowledge of softward (eg Word, Excel, PowerPoint, Adobe Reader)               Ability to organize and prioritizeAble to produce work in teams and within a multi-disciplinary environment Basic Financial Knowledge- must be able to work with financial tracking tools Knowledge of Pharmaceutical Industry R&DExcellent knowledge of Good Clinical Practices, ICH regulations and any others as appropriate and other clinical study regulationsContinuous drive to improve one’s knowledge and performance (in terms of quality, timeliness and costs)Strong organizational, coordinating & coaching plus interpersonal skillsExcellent verbal and written communication skills Show professional awareness and integrity Demonstrate a pragmatic/hands-on approachAbility to work within a team and multidisciplinary & matrix environment, support othersProactive approachFlexibility