Regional Clinical Operations Lead

Title:

Regional Clinical Operations Lead

Company:

Ipsen Bioscience, Inc.

Job Description:

Regional/Local Studies/Programs :

• To provide clinical and operational expertise/guidance for the design, implementation, execution follow-up and closing for local/ Regional Company Sponsor Studies (CSS), Interventional and Non-Interventional Studies (NIS), Early Access Programs (EAP) and Patient Support Program (PSP), as well as direct management support when it deems necessary, within area of responsibility (from preparation & validation to full execution).
• To provide clinical and operational expertise/guidance to Regional/Local Clinical Project Managers (CPM)  and CLINICAL MONITORING LEADs, CLINICAL TRIAL ADMINISTRATORs if applicable  under his/her responsibility in the conduct of the Studies/Programs to allow to meet the objectives, to achieve the key deliverables in terms of quality, performance and cost, budget reviews, to secure the  planning, to ensure proper internal and external resourcing, to secure  communication throughout the course of study/Program   locally, Regionally  and  to Global medical affairs, to put in place and to revisit on ongoing basis risk assessment, to manage all stakeholders,  Regional and/ Or  Global procurement, to set, to revise and to reconcile the study/Program budget from setup to close-out.
• To be held responsible for the oversight of all the ongoing studies and programs in the Region/Country 
• To be the key contact point and representative for all Regional /Local GMA clinical related activities  vis-à-vis of  the TA Medical Directors, Medical Asset Lead, Finance, Legal, Procurement, PV, QA, cross-functional task-forces.
• To participate in selection, management, operational governance of study Service Providers in area of responsibility.
• Support business continuity when resources turnover occurred within his/her Study/Program
• Review ISS / CSS/Program proposals within relevant tools and systems and attend MARB to support the Medical Advisor/MSL  

Processes related to GMA study conduct:

• To adapt changes in processes for continuous improvement and adaptation to business model changes.
• To support Head of GMA ClinOps in cross-functional initiatives within the Region/Country.

Main responsibilities / job expectations

To assess the resources, need, support recruitment (if requested by Head), ensure proper training and certification where applicable

For all Studies and Programs:

• To review study design (esp. timeline, resourcing, and budget assessment) to meet study objectives and achieve clinical and data generation excellence
• To ensure all criteria are met prior Medical Affairs Review Board (MARB )
• To provide guidance in study execution and closing and ensure study plan, budget and deliverables are delivered on time and with expected quality.
• To lead all activities associated with the implementation of clinical studies and programs
• To develop and maintain, for operational management and reporting purposes, a dashboard (Score Cards) to track, reconcile and manage the planning, deliverables and budgets about clinical studies/Programs in the area of responsibility and ensure all needed information is shared with key internal stakeholders (eg Head of GMA Clinical Operations, Medical TA Heads, Medical Asset Leads, R&D Quality, GPS, Finance, …)
• Ensure clinical deviations and Quality events are properly reported, followed and managed
• Accountable to Liaise regularly with Regional/Local Patient Safety Managers and Global Patient Safety (GPS) as well as Quality Assurance, Regional, local, and Global
• Provide support to region/Country to stay inspection-ready by ensuring all trainings, certifications, deviations, documentations, eTMF are properly completed, maintained, filed and archived
• Present study/Program progress at all Quarterly Medical Asset Oversight meetings and escalate any foreseen critical issue
• Referent & Contact points
• To pro-actively act as contact point for internal functions within Ipsen (e.g. TA Medical Directors, Medical Asset Leads, GMA Departments Heads, Drug Development, all other support function heads) and provide operational expertise to all of them
• To provide expertise in GCP or RWE data generation regulations, or in specific therapeutic areas, in order to assess the operational pertinence of considered clinical study design.

Preferred Service Providers (SP):

• To set and follow-up meetings with SP, to consolidate across studies key discussions points (e.g. timelines, recruitment, quality, resources, budget issues). 
• Oversight of the Service Providers “GMA external resources” for the deliverables, timeline sand budget with emphasis on the excellence in execution
• Serve as the first point of study issue escalation for Service Providers
• Support the selection of the Service Providers and privilege the choice of the preferred providers as directed by Procurement/Outsourcing  (Globally, Regionally and locally) 
• To perform any other activity as may reasonably be required by the Head of GMA Clinical Operations from time to time that may include the functions of a part-time CRM to manage a GMA Study, NIS, other.

Knowledge, abilities & experience

Education / Certifications:

Experience:

• Significant and relevant experience (minimum of 10 years) in GLOBAL Medical Affairs with significant and relevant experience (minimum of 10 years) in RWE/HEOR, NIS studies, including project management of national and international programs,
• Experience in pharmaceutical drug development (Ph2, Ph3) including project management of national and international programs is a plus
• Extensive experience and know-how (minimum of 7 years) in Oncology Neuroscience/Rare Diseases or in Rare Diseases or in Neurosciences
• Recent, significant, and successful experience in line-managing people > 5 years,
• Extensive track-record of interactions with country Medical Affairs Staff is a significant plus,
•  Deep knowledge of Good Clinical Practice (GCP) and RWE data regeneration regulations.
• Experience of working with multidisciplinary groups and ability to work within a team environment,
• Experience of managing and developing relationships with Service Providers

Languages:

• French and English
• Computer literacy

Key Technical Competencies Required

• Excellent organizational and management skills,
• Excellent verbal and written communication skills

In order to maintain a safe work environment, Ipsen requires all employees to be fully vaccinated (with booster if eligible) against the Covid 19 virus at the time of employment.

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.