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Clinical Operations Manager, Trial Start-up & Administration

Category:  Clinical Development and Medical
Location: 

Warsaw, Mazowieckie, PL

   

Are you a dedicated clinical operations professional who enjoys working in dynamic and multicultural work environment? Are you passionate about clinical research and have previous experience in people management? Do you care about serving patients fighting with chronic diseases? If yes, we might be looking just for you!

 

The position

As a Clinical Operations Manager, Trial Start-up & Administration you will be an essential member of the CDC Management Team responsible for strategic management of clinical trial administration team, start-up, and clinical supporting processes to ensure the world-class clinical trial execution across 16 countries of CDC Poland. You will be leading a team of managers for trial administration, start-up, and other clinical trial supporting processes in trial delivery (e.g., contracts, budgets, supplies, etc.), including but not limited to:

 

Key responsibilities

  • Developing and executing the trial start-up, administration & other supporting clinical processes management strategy in close cooperation with the CDC Director and Clinical Operations Managers

  • Building and managing the team and planning personal & professional development of the team members

  • Setting and monitoring of performance targets & KPIs for the team & functional area in close cooperation with the with the CDC Director and Clinical Operations Managers

  • Improvement & maintenance of trial administration operational model across CDC

  • Optimisation & centralization of clinical trial supporting processes at the CDC level

  • Managing lifecycle of clinical trial agreements and other contracts, including sub-contractors, across trials and countries 

  • Supervision of trial budget preparation and compliance to budget cycles, benchmarking of costs and FMV across countries

  • Ensuring invoicing and payment related systems and processes are in place for ensure timely study payments to investigators and sites

  • Implementing non-drug supply strategy (e.g., ITMF binders, needles, lab kits) including effective risk management to ensure supply continuity to sites and patients across countries

  • Managing strategic partners/vendors from identification, budget, and contract negotiation to supervision of performance to ensure timely deliverables (e.g., legal agencies, FSPs, translation vendors, equipment suppliers)

  • Partner with cross functional teams like trial delivery, quality, local legal, finance, purchase teams to ensure compliance to local policies and procedures 

  • Representing CDC Poland in cross functional project groups at regional/IO/global levels

  • Participating in and making an effective contribution to CDC Poland Management Team

  • Initiating change aiming at continuous improvement (including digitalisation) of the clinical trial supporting processes and practices

 

Qualifications

  • Minimum 6 years of relevant experience in clinical operations/clinical trials execution in multi-country setting in Pharmaceutical industry or Clinical Research Organization

  • Strong people management (proven min. 3 years’ experience in direct line management)

  • Ability to communicate with impact and build relationships with stakeholders – at country/regional/global level

  • Master level of education

  • Fluency in English – written and spoken

  • Successful delivery of Change Management and fast adoption to new ways of working

  • Experience working in cross functional teams (cross boarders, cross functions)

  • Conceptual and strategic approach to the clinical organization development in multi-country setting

  • Strategic insight to centralization of trial start-up, administration & supporting processes in the clinical trial conduct

  • Ability to gather and make sense of information that suggests new possibilities

  • Good knowledge of current clinical research regulations in Europe

 

About The Department
CDC Poland is part of Region South East Europe, Middle East and Africa (SEEMEA) and is a new set up of clinical organization in Novo Nordisk Poland, covering a group of 16 countries including Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, North Macedonia, Italy, Romania, Serbia, Slovakia, Slovenia and Poland. CDC Poland is responsible for conducting clinical trials across this group of countries, providing clinical trial management and administration support to adjacent Affiliates. CDC Poland is currently responsible for approximately 20% of global patients in Novo Nordisk clinical trials.

 

Working at Novo Nordisk

Novo Nordisk is its people. We know that life is anything but linear, and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing.

 

Contact

We thank all applicants for their interest, however only those candidates selected for interviews will be contacted.

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

 

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