Study Data Manager

A leading international healthcare company is seeking to recruit a Study Data Manager to their team in Switzerland. The organisation is a global provider of automated laboratory instruments and solutions that develops, produces, markets, and supports automated workflow solutions that empower laboratories to achieve more. This vacancy is an excellent opportunity to work with a highly prestigious organisation whose historic presence has been a cornerstone in the pharmaceutical industry.

Job Responsibilities:

• Operates as the core representative for Clinical Data Management (CDM) on the study team and to be accountable for the collection, review, and management of data, ensuring deliverables are met.
• Leads the CDM study team in maintaining oversight of all build, conduct, and close activities for one or more studies, ensuring fit for purpose quality.
• Leads the CDM study team and maintains oversight of all build, conduct, and close activities for one or more studies, ensuring fit for purpose quality.
• Implements study conventions, processes, knowledge sharing, and best practices on assigned study(ies).
• Leads the CDM study team and maintains oversight of all build, conduct, and close activities for multiple or complex studies, ensuring fit for purpose quality.
• Implements study conventions, processes, knowledge sharing, and best practices on multiple or complex studies.
• Leads the CDM study team and maintains oversight of all build, conduct, and close activities for one or more studies, ensuring fit for purpose quality.
• Implements study conventions, processes, knowledge sharing, and best practices on assigned study(ies).
• Utilizes communication tools.
• Effectively communicates study goals and status of work, including all requirements to CDM study team and stakeholders.
• Shares knowledge using relevant forums and communication tools.
• Effectively communicates study goals and status of work, including all requirements to CDM study team and stakeholders.
• Leads proactive sharing of knowledge using relevant forums and communication tools.
• Effectively communicates at the Business Process Owner (BPO) level with the ability to share information with relevant stakeholders.
• Strategic Agility With direction, manages CDM study deliverables, including timelines, risks, and coordination of cross-functional tasks.
• Understands study issues and implements corrective action plans, evaluates risk, and implements risk mitigation plan at the study level.
• Manages CDM study deliverables, including timelines, risks, and coordination of cross-functional tasks.
• Identifies and escalates study issues appropriately and addresses corrective action plans.
• Evaluates the impact of risks and develops and implements mitigation plans at the study level.
• Manages CDM deliverables, including timelines, risks, and coordination of cross functional tasks on multiple or complex studies.
• Proactively develops solutions to complex problems.
• Proactively reviews risk and develops contingency plans at the study level.
• Sets targeted timeframes for deliverables and proactively influences and negotiates positive outcomes for CDM on technical/functional deliverables.
• Resolves cross-functional problems and proactively identifies process gaps and the piloting of innovative solutions.
• Proactively develops contingency plans to reduce impact of risks to technical/functional strategies.
• Receives coaching and mentoring on sub functional activities.
• Provides timely feedback to individuals and to CDM Management and seeks ongoing feedback for personal.
• Provides coaching and mentoring on sub functional activities to peer Study Data Managers (SDMs) and associate Study Data Managers (aSDMs).
• Provides timely feedback to individuals and to CDM.
• Identifies gaps in Study Data Manager (SDM) knowledge and provides coaching and mentoring on sub functional activities to SDMs and/or raises gaps to Program Data Leader (PDL) and CDM Management.

Skills and Requirements:

• Extensive experience in one or more CDM functions.
• Ability to apply highly advanced principles, theories, and strategies to one or more sub functions within CDM.
• Consistent demonstration of ingenuity, creativity, and resourcefulness.
• Ability to apply advanced principles, theories, and concepts for one or more sub functions within CDM.
• Grasp of trends in the industry and applies them to work within the organization.
• In-depth understanding of the business of their sub function and the wider CDM organization.
• Knowledgeable of theories and principles of CDM and how to apply them within their sub function.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Tom Magenis at +44 203 854 1050 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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