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Senior Manager, TAT/Integration Clinical Operations

Employer
Ipsen Biopharmaceuticals, Inc.
Location
Cambridge
Start date
Jun 9, 2024

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Job Details

Title:

Senior Manager, TAT/Integration Clinical Operations

Company:

Ipsen Bioscience, Inc.

Job Description:

TAT/Integration Clinical Operations (Senior) Manager (TAT/Integration COM)

Purpose of the position

The TAT/Integration COM will serve as a core member of the CDO teams in charge of TAT and/or Integration activities ensuring successful onboarding / transition / integration of new assets and CDO team members across all Therapy Areas (TAs).

The TAT/Integration COM will provide Clinical Operations expertise to integrate any new assets at Ipsen and will collaborate and support the DDI & TAT CPD in the transition of the acquired clinical studies to Ipsen.

For TAT activities, the TAT/Integration COM will take responsibility for overseeing the CRO clinical /site management activities of the acquired clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and applicable SOPs in order to assist in the delivery of Clinical Development objectives during the transition phase.

For acquired company and/or asset Integration, the TAT/Integration COM will drive and manage clinical operations related integration activities to ensure successful onboarding of any new CDO members into Ipsen and/or ensure efficient and smooth transition of acquired clinical trials into Ipsen ways of working.

Main responsibilities and tasks

TAT activities

During the time the TAT is responsible for the asset, the TAT/Integration COM will assess the clinical operations activities of the new asset, including gap analyses, and will prepare the transition plans in collaboration with the DDI & TAT CPD and will conduct in-house and external clinical operations activities, as applicable, to ensure full integration of the clinical studies into Ipsen ways of working:

  • Review study status vs planned activities, assess any impacts and/or risks and provide recommendation to the DDI & TAT CPD for any mitigation actions, as required.
  • Manage any clinical study activity delegated by the DDI & TAT CPD, such as the project management and monitoring of clinical studies, including liaison with monitors, CROs, drug vendors, central laboratories and other vendors, as applicable.
  • Oversee the CRO clinical and site management activities to monitor adherence to study protocol, regulatory requirements and GCP guidelines.
  • Participate in study feasibility as applicable and lead the site feasibility assessment (CDA preparation and collection; Study questionnaires to sites etc…).
  • Collect the relevant study information and set up clinical study dashboard as per Ipsen way in collaboration with the TAT CPD.
  • Organise appropriate logistics for any Sponsor meetings and all internal study team meetings as applicable.
  • Perform the assessment and track the new asset clinical studies external vendor contracts /change orders, including gap and impact analysis, in collaboration with the procurement and legal teams.
  • Collaborate, with the procurement and legal teams on the preparation of transition plans for existing contracts, generation of contract templates, ensure contracts are fully executed and archived and collection of any legal documents as needed.
  • Collaborate with the insurance department team for tracking the status of clinical trial insurance, preparing any transition plan for any existing clinical study insurance, and proactively request insurance certificate and renewals.
  • Coordinate the dispatch order for the clinical supplies if not managed by a dedicated system such as IVRS, meaning the collection of appropriate documents permitting to obtain import license and release study drugs in collaboration with the CMC Supply Chain team.
  • Coordinate the collection of appropriate study essential documents, such as Clinical Study Report (CSR) appendices within the agreed timeframe, and validate the accuracy of contents against the actual study status in collaboration with the CRM/CPM to support the medical writer assigned to the study.
  • Prepare and execute the transition plan for the new clinical asset electronic Trial Master File (TMF) (and/or paper TMF, if applicable) to ensure full integration and compliance with Ipsen processes.
  • Manage and track the study financial documents, including commitment requests, Internal Order, Purchase Order, goods receipt & invoices, within the Ipsen financial K2 system, as applicable and support the clinical study budget management and monitoring according to the financial control process.
  • Assess the new clinical asset disclosure of expense collection and reporting process and prepare a transition plan in collaboration with the DDI & TAT CPD and the Local Transparency Manager (LTM) or the Global Transparency Manager (GTM) to track, collect and disclose study expenses according to Ipsen processes and in compliance with regulations in force: EFPIA disclosure code (Europe), Sunshine Act (US).
  • Assess the new clinical asset reporting tool and/or CTMS and prepare a transition plan in collaboration with the DDI & TAT CPD, ensure all required study data are properly tracked and always up to date in the eCTMS.
  • When needed, conduct or coordinate the Service Provider or internal team trainings to Ipsen tools or processes.
  • Set-up and maintain up to date shared CDO transitional folders and study electronic site (SharePoint, box or other tools).
  • Ensure successful handover of Clinical Operations activities to the Study Team/Asset team assigned to take over the project from the TAT team.

Integration Activities

The TAT / Integration COM will drive and manage clinical operations-related integration activities to ensure effective integration and business continuity for any assigned clinical asset acquisition.

  • Be active member of CDO Integration team supporting the DDI & TAT CPD and proactively lead some sub-meetings for the transition of Clinical Operations Activities to Ipsen Ways of Working. This includes but not limited to SP/Vendor scope of work/agreement, TMF, CTMS, expenses transparency, insurance, data transparency and regulatory disclosure and financial aspects.
  • Manage, prepare and collect relevant clinical operation documentation to be appended to the change control and the Integration Story Board.
  • Coordinate the preparation and communication of the Integration newsletter.
  • Contribute to the Q&A sessions with the acquired legacy CDO team, as applicable.
  • As assigned by his/her line manager, onboard, mentor or train new team members.

Operational Excellence Initiatives

  • The TAT / Integration COM will be an active member of the clinical trial excellence initiatives within CDO.

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

Education/Experience:

Minimum:

  • 3-year relevant scientific focused degree
  • 4-6 years relevant work experience within clinical research /study management environment

Ideal:

  • 5-year degree with a scientific, clinical or research focus
  • 5-8 years clinical trial management experience.
  • Advanced degree at Master level an advantage.

Language:

  • English: Fluent to Strong intermediate level (spoken, written) is required

Key Required Technical Competencies

  • Minimum: Knowledge of the clinical study environment with a strong theorical or practical administrative organization.
  • Scientific background is an asset.
  • Comfort with work in any therapeutic area on any drug as the TAT team is assigned to any asset in any stage of development. Therefore phase 1 to phase 3 experience is essential.
  • Experience working with multidisciplinary groups and ability to work within an asset team environment
  • Experience managing and developing relationships with Contract Research Organisations (CROs)
  • Experience coordinating, compiling and tracking clinical study budgets.
  • Excellent organisational and prioritization skills, with strong attention to detail
  • 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)
  • Intermediate Financial Knowledge- must be able to work with financial tracking tools
  • Knowledge of Pharmaceutical Industry R&D
  • Good knowledge of the Good Clinical Practices (GCP) or other clinical study regulations
  • Experience supporting the transition of clinical asset in or out is an advantage.
  • Ideal: strong experience in clinical study environment within CRO or Pharmaceutical company.

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.

Company

Ipsen (Euronext: IPN; ADR: IPSEY) is a global, biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neuroscience and Rare Diseases. At Ipsen, we focus our resources, investments and energy on discovering, developing and commercializing new therapeutic options to provide hope for patients whose lives are challenged by difficult-to-treat diseases. Ipsen's North American operations and headquarters are located in Cambridge, Massachusetts, where our fully integrated biopharmaceutical team across External Innovation and Partnering, Research & Development (R&D), Manufacturing and Commercial collaborate. Cambridge is home to Ipsen's third global hub, in addition to R&D centers in Paris-Saclay in France and Oxford in the United Kingdom. With additional offices in Basking Ridge, N.J. and Mississauga, Ontario, Ipsen employs approximately 600 people in North America. For more information on Ipsen in North America, please visit www.ipsenus.com or www.ipsen.ca.

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Company info
Website
Phone
617-679-8500
Location
1 Main Street
Unit 700
Cambridge
MA
02142
US

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