Senior Manager, TAT/Integration Clinical Operations

Ipsen•Cambridge, MA

14d

About The Position

This role will serve as a core member of the CDO teams in charge of Integration and Due Diligence activities ensuring successful Due Diligence assessment and onboarding / transition / integration of new assets and CDO team members across all Therapeutic Areas (TAs). This role 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 acquired company and/or asset Integration, this role 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. For Due Diligences, this role will provide Clinical Operations expertise input in collaborating and supporting the DDI & TAT CPD in the assigned Due Diligence activities.

Requirements

6 years relevant work experience within clinical research /study management environment
Knowledge of the clinical study environment with strong theoretical or practical administrative and organizational capability
Ability and comfort to work in any therapeutic area, drug and development stage, with Phase 1 to Phase 3 experience essential, primarily focused on oncology, neuroscience and rare diseases, including pediatric research.
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 within a highly regulated environment and quality management system (QMS)
Advanced knowledge of standard software applications (for example Word, Excel, PowerPoint, Adobe Reader)
Intermediate financial knowledge with the ability to work with financial tracking tools
Knowledge of pharmaceutical industry research and development
Good knowledge of Good Clinical Practices (GCP) and other applicable clinical study regulations
3-year degree in a relevant scientific, clinical, or research focused field required
Fluent in English.

Nice To Haves

Experience within a CRO or pharmaceutical company clinical study environment is an advantage
Experience of regulatory inspections and/or GCP audits is an advantage
Experience supporting the transition of clinical assets in or out is an advantage
Master’s degree or higher in a relevant scientific, clinical, or research focused field strongly preferred
French is an advantage.

Responsibilities

Assess the clinical operations activities of the new asset, including gap analyses, and prepare the transition plans in collaboration with the DDI & TAT CPD, and manage clinical operations-related integration activities to ensure effective integration and business continuity for any assigned clinical asset acquisition.
Support /lead, as assigned, the DDI & TAT CPD in the development and update of integrated processes, guidelines and plans for harmonizing and optimizing CDO integration activities with a continuous improvement mindset.
Support /lead, as assigned, the DDI & TAT CPD in the development of CDO Key Performance Indicators and reporting dashboards for integration activities.
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.
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.
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.
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.
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 (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.
Participate in the CDO Due Diligence activities assigned by his/her line manager, collaborating with the DDI & TAT CPD by providing Clinical Operations expertise input to support the Due Diligence assessments.
Support /lead, as assigned, the DDI & TAT CPD in the development and update of integrated processes, guidelines and plans for harmonizing and optimizing due diligence CDO assessment with a continuous improvement mindset.
Support /lead, as assigned, the DDI & TAT CPD in the development of CDO Key Performance Indicators and reporting dashboards for integration activities.
Conduct thorough review of available data in the virtual data room for assigned due diligence assessments.
Identify missing due diligence documentation and information, and coordinate with DDI and TAT CPD to ensure timely submission of the appropriate Clinical Operations requests during due diligence.
Provide CDO expertise ensuring appropriate risk assessments and mitigation strategies, and ensure review/validation by applicable CDO, Due Diligence and Integration assignees.
Support DDI & TAT CPD in the external clinical development cost estimates and associated CDO/biometry resource and capacity needs for assigned due diligence assets.
Contribute to the clinical trial excellence initiatives within CDO.
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.