Section Manager Clinical Operations EMEA (m/f/d)

at  Olympus Europa SE Co KG OEKG

Your responsibilities
The Section Manager, Clinical Operations EMEA manages and supports the regional (EMEA) Clin. Affairs team, and collaborates closely with the global Clinical Affairs Team as well as regional Business Heads to run all aspects of clinical studies in support of clinical evidence generation across the Endoscopic Solutions Division (ESD) and the Therapeutic Solutions Division (TSD) business unit portfolios.
In this function the Section Manager Clinical Operations EMEA will manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication, working closely with supporting functions to drive evidence and dissemination strategies. He/She is responsible for ensuring that clinical activity is completed on time and within budget and in line with GCP, EMEA’s Clinical SOPs and WIs and Olympus Global Rules and applicable laws and regulations.
Additionally, this role will support activities such as clinical evaluation reporting (CER), PMCF planning, and Labeling and promotional material review processes.

Furthermore:

• Clinical point of contact for OEKG, OSTE and Global BUs to provide insights into clinical strategies and develop future activities and projects in line with business objectives. Available to provide consultation towards BUs wherever Clinical Affairs knowledge is required.
• Supervise and lead the activities of the EMEA-Clinical Project Managers (CPMs) and other direct reports related to the design, management, and execution of clinical studies for worldwide product approval of Olympus’ portfolio or for other clinically relevant purposes. This includes but is not limited to the creation and review of essential clinical study documents like preparation of clinical investigation plans and protocols, site selection, site approvals (including ethics committee), site budget and contracting, site training and logistics, case report forms,study binders, monitoring, safety reporting and outsourcing of selected tasks.
• Supervise and coordinate proper assessment of external requests for support of Investigator Initiated Trials according to regional / global policy.
• Support global harmonization efforts by implementing regional and global clinical affairs procedures, ensuring regional legal, and clinical requirements / guidelines are met. Oversees clinical compliance and team performance according to all international and regional standards/regulations.
• Identify and cultivate talents by providing leadership, career development, coaching and mentoring to direct reports.
• Set individual goals of direct reports in line with overall clinical strategy, provide feedback and rates individual performance and achievements.
• Stay abreast of changing regulations and guidance documentation affecting clinical studies ensuring that EMEA Clinical Affairs remains compliant with all regulations and guidelines within targeted geographies and share with the team as appropriate. Ensure that all company sponsored trials are audit ready anytime.
• Review and approve clinical study reports and clinical sections of regulatory submissions written by the CPMs. Actively participates in responses during regulatory review processes. Engage in Clinical Development Plan during Product Development Phase.

• Deliver dashboards, reports and analytics to leadership, as required. Collaborate with project management to ensure that clinical trial-related tasks, milestones, and deliverables are met within required timeframes. Review, analyze and interpret study data and assist in preparation of reports for publication. Build and maintain a strong network and close relationship with investigative site personnel, investigators, and internal stakeholders.Other duties as assigned.

Your qualification

• Required: MA/MS or PhD degree in life sciences or related field
• Minimum 5 (-7) years of medical device / pharmaceutical industry experience in Clinical Affairs/Operations or Medical Affairs (preferably in multiple phases and multiple roles).
• Preferable first experiences in line management and/or related trainings/seminars, or the willingness to participate in such trainings/seminars.
• Budget and forecasting experience
• Organizational Savvy: Understands how work gets done in matrixed organizations; builds productive relationships that allow him/her to efficiently drive projects; maintains a results orientation within constraints of formal organizational policies and rules.
• Customer Focus: Builds productive relationships with internal and external stakeholders; stays cognizant of stakeholder needs, concerns and satisfaction; responds promptly to stakeholder questions and requests; effectively manages stakeholder expectations.
• Situational Adaptability: Maintains a positive attitude in the face of change; appropriately adjusts behaviour and activities to changing conditions in the business environment.
• Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences. Strong managerial and negotiation skills.
• Collaborates and is a team player. Ability to work well with diverse individuals / cultures both inside and outside Olympus.
• Driving for Results: Aggressively pursues challenging goals and objectives; willing to devote considerable time and effort to accomplish objectives; takes a highly focused, goal driven approach toward work.
• Ensures Accountability: Clearly defines and communicates roles and responsibilities; holds people accountable for accomplishing objectives; recognizes and rewards people who achieve results and deliver on performance expectations; provides effective feedback on performance.

Your competencies

The interview will be competence based and the following competencies will be assessed:

• Build for the Future
• Deliver Results
• Lead People
• Lead Self
• Model and champion Our Core Values

Your benefits

• Flexible working hours, remote work possible (up to 60%)
• 30 days of holidays per year
• Modern office and an inspiring working environment
• Employee restaurant with live cooking and healthy food (subsidized)
• Public transport ticket (100 % subsidized) or free parking space
• Company sport groups and an inhouse company gym
• Employee Assistance Program to support your health, mental and emotional well-being
• A comprehensive company pension scheme
• Company medical officer and vaccination offers
• Childcare through our ‘Buttje&Deern’ partner
• Bike leasing

Please refer the Job description for details