Senior Clinical Monitoring Lead

Senior Clinical Monitoring Lead

Ipsen Pharma

Cambridge, United Kingdom

Summary/Purpose of the position

Take responsibility for coordinating the clinical monitoring activities, overseeing the CRO clinical /site management activities and co-monitoring the assigned international Phase I to III 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.

Be an Ipsen Ambassador at site and build strong relationship with our investigators.

Coordinate the achievement of assigned clinical study deliverables within a matrix organization under the leadership of the Clinical Project Managers (CPM). As Senior CML, takes responsibility of some study oversight in agreement with the CPM as described below.

Can be designated as CML lead for studies where several CML are assigned: coordinating other CMLs to secure all task completed as per plan and be CML point of escalation, reporting to the study assigned CPM.

Main responsibilities/job expectations

Responsibilities include, but are not limited to the following:

Ensure clinical activities coordination & oversight:

• Ensure efficient and thorough study feasibility, either directly if internally managed, or by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study feasibility (MDD, Reg, digital etc.…): ensure feasibility assessment is appropriately managed and reports are exhaustive. Prepare or Review site feasibility reports as per oversight plan, as applicable and support the CPM in site selection.
• Ensure efficient and thorough study start-up, either directly if internally managed, or 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.…):Verify timely collection of essential study documents, such as regulatory and ethics committee documents for submission, oversee site Clinical Trial Agreements preparation and control that all set up activities are performed prior to each site initiation, as per the oversight plan.
• Support and ensure that all specific Ipsen/CRO EDC and/or eCOA system tasks under the clinical responsibility are completed and achieved according to the defined timelines without jeopardizing the start of a trial.
• Ensure CRO CRAs are appropriately trained to study protocol and support the Clinical CRO in the training of the CRAs on all study specific operational activities and participate in the organization 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.
• Participate to the preparation of the internal Oversight Plan and review/comment associated documents managed by the CRO that are necessary to oversee the clinical activity implementation, monitoring and reporting in a professional, high quality and timely manner (such as monitoring oversight plan and clinical monitoring metrics…).
• Customize site Key Risk/Performance Indicator template and follow these KRIs/KPIs at frequency agreed in the oversight plan.
• Review 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 (Ipsen 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 meeting.
• If 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 recruitment).
• If applicable be the main CML contact for other study CMLs and ensure task and delegation between CML team is in place.
• If applicable collate/review the feedback/findings from all CMLS to provide a holistic overview for the CPM/study team and assess for trends.
• Be responsible for oversight and financial management of third-party vendors as agreed with CPM (i.e., IWRS, Central lab).

Ensure the monitoring oversight of different activities entrusted:

• Be an IPSEN Ambassador at site: create and build relationship with our Investigators, by discussing patient pathways, recruitment challenges and any other study specific topics in a problem-solving mindset, for Ipsen to become their partner of choice.
• Perform co-visits 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. Co-monitor at site if required.
• Participate in the ongoing clinical study data reviews in collaboration with the other study team members. Manage and oversee the allocation of the reviews within the CML team as applicable.
• Make appropriate and timely reporting in Ipsen’s Clinical Trial Management Tracking System, with regular checks for quality and accuracy.
• In collaboration with the data transparency team, review, and update CT.GOV details under the supervision of the CPM.
• Review metrics obtained from Data management and monitoring CRO for data collection (CRF/eCRF) and data clarifications/queries and make sure that agreed timelines are met. Report to CPM and study team such status with appropriate mitigation proposal when issues are met. Where applicable, ensure with CRO that improvement plan is set-up and conducted appropriately.
• Ensure that study imaging/samples/assessments flow as required per protocol is well coordinated between the various stakeholders (CROs/Vendors/Ipsen departments) from site to the central facility/specialized lab and that Ipsen get appropriate reporting of their status.
• 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 archiving.
• Participate in the preparation and follow-up of any other study systems (such as IWRS/IMP forecasting/ flow etc.…), as required.
• Maintain 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.
• Perform 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.
  • take on certain allocated CPM responsibilities.

Clinical activities (out of studies):

• Contribute/participate on SOP update and review training material created by Process Training Management.
• Contribute to the efficient operation of the TA Group and to transversal project cross- Tas and other departments within Ipsen (e.g., systems implementation, change management initiatives, continuous improvement initiatives …).
• Onboard and train new CMLs joining the company.

EHS responsibilities:

• Comply with applicable EHS regulations and procedures.
• Participate in the site’s EHS performance by reporting risks, malfunctions, or improvements.
• Participate in mandatory EHS training.

Knowledge, abilities & experience

Education/Certifications:

• Life science or medical graduate or other relevant qualifications.
• Minimum: CRA graduated.

Experience:

• Relevant experience of pharmaceutical drug development.
• Experience of minimum 3 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) or 2 years’ experience as CML. (or a combination between the 2).
• Experience as a Field CRA monitor for at least3 years (CROs or Pharma Industry).
• Excellent Knowledge of Good Clinical Practice (GCP), ICH regulations.
• Strong Experience in preparing clinical study documentation for study set up, maintenance and closing.
• Strong Experience in managing and developing relationships with Contract Research Organizations (CROs).
• Global studies (multiple countries/sites) experience.
• Previous experience in the Therapeutic area of studies (Neuroscience, Oncology, or radiopharmaceutical compound, etc..) is a plus.

Languages:

• English: Strong intermediate level.

Key Technical Competencies Required

• Ability to work in a strong regulated environment within a quality management system (QMS).
• Advanced knowledge of software application (ex: Word, Excel, PowerPoint, Adobe Reader …).
• Excellent organization skills and strong Ability to prioritize.
• Able to produce work in teams and within a multi-disciplinary environment.
• Financial Knowledge- must be able to work with financial tracking tools.
• Strong Knowledge of Pharmaceutical Industry R&D.
• Excellent knowledge of Good Clinical Practices, ICH regulations and any others as appropriate and other clinical study regulations.
• Continuous drive to improve one’s knowledge and performances (in terms of quality, timeliness, and costs).
• Strong coordinating & coaching plus interpersonal skills.
• Excellent verbal and written communication skills.
• Ability to interact and develop good relationship with external stakeholders such as investigators and site staff or patient association groups.
• Show professional awareness and integrity.
• Demonstrate a pragmatic/hands-on approach.
• Ability to work within a team and multidisciplinary & matrix environment, support others.
• Proactive approach.
• Flexibility.
• Travel Requirements: Domestic or international travel may be required. The position is predominantly office based though travel will be a necessary pre-requisite in order to effectively support the Group and the projects, with a 25% estimated average travel time.

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