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Clinical Study Manager-2

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Roche

On-site

On-site

Regular employment

2 - 15 years of experience

Full Time

Sofia, Bulgaria

Responsibilities

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

The Opportunity

You are a talented and flexible professional with certain medical/pharmacy/clinical/science experience in the clinical trials. The Country Study Manager functions as a subject matter expert on all Study management activities specific for a country level; oversees and works in close collaboration with other Study Team member (SSUS, CRA, CTA etc.) and other stakeholders (Scientific Enablers a.k.a. Medical Managers); acts as leader in the field of clinical trial execution by adopting the appropriate patient recruitment strategies.


Your responsibilities:

  • Provides leadership and local strategic planning and organization skills to ensure the effective and efficient delivery of operational aspects of one or more studies through all phases of study management (preparation, study start-up, conduct, close-out), in accordance with the appropriate quality standards including ICH/GCP/GPP standards, Roche SOPs, local operating guidelines and local requirements, timelines and budget commitments. 

  • For Global/Regional Studies (referred to in rest of this document as Global), the CSM leads and has full accountability (time, quality, cost) of all Affiliate related aspects of a study and ensures delivery of country/regional operational aspects in alignment with the study plans provided by the global Study Management Team (SMT). 

  • For Local Studies, the CSM acts as study leader and, in addition to the above, provides the leadership and clinical operational expertise for local study team. 

  • Leads local study teams, represents Country/Region Clinical Operation at the global SMT, and provides Global Teams with feedback from an Affiliate perspective (Global Studies).

  • In conjunction with local Head of Clinical Operations, Therapeutic Area Leader (TAL) and/or Medical Manager (aka Scientific Value Enabler) or the Country Medical Director (aka Medical Lead), ensures relationships with key investigator sites, alliance partners and/or collaborative groups are optimized to ensure efficient and smooth conduct of the study.

Who you are

You are someone who wants to influence your own development. You are looking for a company where you have the opportunity to pursue you interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.

You’re a team player, able to work under pressure, tight deadlines and tough targets and employ all your creativity to be successful.

The ideal candidate fulfills the following requirements:

  • BSc/MSc. degree, ideally in healthcare, e.g., pharmacy/medicine, nursing etc.

  • Good command of English / MS Office Applications.

  • Very good organization, prioritization and planning skills.

  • Very good communication skills.

  • Analytical skills. 

  • A team player who can easily adapt and integrate into different business cultures.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.


Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

Required skills

Analytical Skills
Communication Skills
Planning
Prioritizing
Program Management
Strategic Planning
Recruitment
GCP
MS Office Tools
Organizational Skills
Bulgarian
English
Job posted 8 days ago

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