Clinical Monitoring Lead - Cambridge, United States - BioSpace

Description

Job Details

Title:
Clinical Monitoring Lead

Company:
Ipsen Bioscience, Inc.

Job Description:

Clinical Monitoring Lead (CML)

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 Ph2/3 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 an Ipsen representative at site and build relationship with our investigators.

Main responsibilities and tasks:

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 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 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)

Ensure the monitoring oversight of different activities entrusted

• Co-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 (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

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

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 ...)

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

Experience / Qualifications

Experience:

Relevant experience of pharmaceutical drug development:

• 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).
• Experience as a Field CRA monitor for at least 3 years (CROs or Pharma Industry)
• Excellent Knowledge of Good Clinical Practice (GCP), ICH regulations.
• Experience in preparing clinical study documentation for study set up, maintenance and closing
• 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

Qualification:

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

Language:

• English: Strong intermediate level

Key Required Technical Competencies

• 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 ...)
• Ability to organize and prioritize
• Able 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&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 organizational, coordinating & coaching plus interpersonal skills
• Excellent verbal and written communication skills
• 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

The annual base salary range for this position is $112,500-$165,000.

This job is eligible to participate in our short-term incentives program.

At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.

The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.