Clinical Site Manager
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The Position
The Clinical Site Manager is responsible for designing, planning, coordinating and conducting all activities involved in initiating, monitoring, and completing clinical research studies in the clinical study sites and delivering as appropriate other data generation methodologies.Work independently to ensure studies are delivered, recorded and reported in accordance with protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements.
Key Accountabilities
The key accountabilities for this position include, but are not limited to:
- Act as primary contact and clinical trial expert for assigned study site personnel for execution of the study - including training and coordinating certification of study site personnel and provide technical assistance, as necessary
- Perform site assessments/site qualification visits in the site selection decision process
- May participate in and ensure site activation (contracting, IRB/EC/Health Authority approvals are, etc.) are properly obtained, maintained and meet regulatory requirements in collaboration with relevant RDS Functions prior to initiation of the investigational site
- Develop key study site documents (e.g. Study Monitoring Plan, informed consent documents, source documents, patient instruction guides and case report forms, etc.) and contributes technical expertise in the review of study protocols, data management plans, reports and manuscript, etc
- Collaborate cross-functionally with R&D, Field Service, Study Management, Biometrics, etc. to deliver best solutions
- Deliver all data generation/validation and site monitoring activities including end-to-end site visits per relevant regulations and processes
- May participate in the oversight of CRO delivery of Site Management activities, including training of CRO CRAs. This includes escalation of any issues
- May work with international investigators and key customers as well
- May coach colleagues and help others develop expertise/skills
- Work independently and is autonomous
Responsibilities
The following are responsibilities for the individuals in this position:
- Adhere to regulations, guidelines and standard operating procedures, and ensure ongoing audit/inspection readiness
- Validate product performance claims, supply data for critical Regulatory submissions, define the functional and clinical utility of our products, and obtain the opinions and input regarding our products from laboratories or customers
- Execute Site Management activities for sponsored studies for assigned area of focus for registrational and/or non-registrational purposes through all study phases (start-up, conduct and close-out)
- Work in local and global study teams, including virtual teams and exhibit diversity and cultural awareness
- Build and maintain strong, collaborative relationships with cross-functional team members, relevant internal and external stakeholders, in meeting business goals and ensuring operational excellence
Requirements
The following are requirements for the individuals in this position:
- Relevant experience in the field
- Bachelor's Degree in scientific discipline or related field required, or equivalent combination of education and work experience, experience in a clinical laboratory, clinical lab study coordination is a plus
- Solves potentially complex problems by analysing possible solutions using experience, judgement and precedents
- Explains complex information to others in straightforward situations
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Our UK Diagnostics business, headquartered in Burgess Hill, West Sussex, employs approximately 560 highly skilled individuals. We provide the industry's broadest range of diagnostics and monitoring products & services, spanning all sectors of the market: from small hand held devices used directly by patients or healthcare professionals, to large diagnostic instruments found in hospital laboratories.
The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd.At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age.
We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.