Clinical Monitoring Lead

Ipsen•Cambridge, MA

About The Position

As Clinical Monitoring Lead, you will be responsible for coordinating clinical monitoring activities across assigned international Phase studies. This includes overseeing CRO clinical and site management activities, conducting co-monitoring visits, and ensuring all activities are executed in compliance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and internal SOPs. Your focus will be on ensuring timely delivery and budget adherence to support the successful execution of Clinical Development objectives and uphold the highest standards of clinical excellence. You will work within a matrix organization under the leadership of Clinical Project Managers (CPMs) to ensure study deliverables are met. Additionally, you will serve as an Ipsen representative at clinical sites, building strong relationships with investigators and fostering site engagement throughout the study lifecycle.

Requirements

8+ years’ relevant experience in pharmaceutical drug development, with significant involvement in clinical research roles.
Minimum 1 year (ideally 2 years) as a Lead CRA, coordinating clinical/site management activities for international registrational studies (multiple sites/countries).
At least 3 years’ experience as a Field CRA monitor (CROs or Pharma Industry).
Experience managing and developing relationships with Contract Research Organizations (CROs).
Demonstrated experience preparing clinical study documentation for study set-up, maintenance, and close-out.
Experience working on global studies (multiple countries/sites).
Excellent knowledge of Good Clinical Practice (GCP), ICH regulations, and other relevant clinical study regulations.
Knowledge of Pharmaceutical Industry R&D and ability to work in a highly regulated environment within a Quality Management System (QMS).
Advanced proficiency with software applications (e.g., Word, Excel, PowerPoint, Adobe Reader) and basic financial knowledge (including use of financial tracking tools).
Strong organizational, coordination, interpersonal and coaching skills; able to organize, prioritize, and manage multiple tasks and deadlines.
Excellent verbal and written communication skills.
Ability to work effectively within teams and in a multidisciplinary, matrix environment.
Demonstrates professional awareness, integrity, a pragmatic/hands-on approach, and a proactive, flexible attitude.
Commitment to continuous learning and improvement in quality, timeliness, and cost-effectiveness.
Degree in life sciences, medicine, or other relevant field.
Minimum requirement: Clinical Research Associate (CRA) qualification.
Fluent in English.

Nice To Haves

Previous experience in relevant therapeutic areas, such as Neuroscience, Oncology, or radiopharmaceutical compounds is considered a plus.

Responsibilities

Ensure clinical activities coordination & oversight
Ensure 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 Ipsen/CRO EDC system tasks under the clinical responsibility are completed and achieved according to the defined timelines without jeopardizing 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 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.
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 clinical monitoring metrics…).
Customize site Key Risk/Performance Indicator template and follow these KRIs/KPIs at frequency agreed in the oversight plan.
Validate 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 (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)
Participate in the ongoing clinical study data reviews in collaboration with the other study team members.
Make appropriate and timely reporting in CTMS (Ipsen’s Clinical Trial Management Tracking System), 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/Ipsen 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 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.
Be an IPSEN ambassador at site and create relationship with our Investigators.
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.
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 …)
For company acquisitions or licensed assets, as requested, provide subject matter expertise in effective integration planning, implementation and monitoring of integration activities within the CDO integration team in collaboration with CDO integration Lead.
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.
Complete all the above activities within the framework and in compliance with Ipsen Global SOPs and other documentation in force within the Ipsen Group.