Senior Study Manager job in Brussels, Belgium

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Last Name*

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Project/Study Manager (CSM/CPM)

Location: Belgium

This vacancy has now expired. Please see similar roles below...

Proclinical are working with a top CRO who are looking for a senior study manager. The job is client dedicated and is performed remotely. The client has locations worldwide and is has improved the lives of thousands of people worldwide, with a clear career progression path.

Responsibilities:

Managing 1 or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies.
Leading one or more clinical studies from study startup through database release.
Provides quality oversight to the Contract Research Organisation (CRO) and of the CRO deliverables related to study execution.
Leads and coordinates the execution of a clinical trial from Study start-up through Database release and inspection readiness to ensure timely delivery of quality study data. Study Managers may also input to and support compilation of sections to Clinical Study Reports.
Providing leadership to the teams in the setting of realistic targets and milestones.
Working with functional lines and directly with CRO line functions to resolve or triage site level issues.
For studies where more than 1 Study Manager is assigned, may be required to act as 'lead' study manager and will coordinate activities of the other Study Managers assigned.
Responsible for the development of realistic detailed study startup and monitoring plans.
Reviewing Pre-trial Assessment outputs, approving sites, and assessing site activation plans.
Coordinating study/protocol training & investigator meetings.
Leading the inspection readiness activities related to study management and site readiness.
Producing and reviewing model Informed Consent Document (ICD) and study/country/site level ICD, as appropriate.

Qualifications
External Training and Education Preferred:

Extensive global clinical trial/study management experience.
Knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations.
Bachelor's degree: minimum of 5 years relevant experience.
Master's degree or PhD - minimum of 3 years relevant experience.
Demonstrated study management / leadership experience / oversight of CROs.
Experience in managing Per Subject Costs, vendor & ancillary, and monitoring costs projections & spend.
Ability to interpret study level data & translate and identify risks.
Ability to proactively identify & mitigate risks around site level in study execution.
Understands feasibility of protocol implementation.
Keen problem-solving skills.
Excellent communication skills, both written and verbal in English.

If you are having difficulty in applying or if you have any questions, please contact Asad Ali at +32 2 446 01 53.

Proclinical 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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