Senior Study Manager - Client-Dedicated

The Senior Study Manager (SSM) has responsibility for one or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies

• Lead and manage the tactical execution of one or more clinical studies from study startup through database release and inspection readiness to ensure timely delivery of quality study data.

• Provides quality oversight to the Contract Research Organization (CRO) and of the CRO deliverables related to study execution

• Provide input to and support compilation of sections to Clinical Study Reports

• Provide leadership to the teams in the setting of realistic recruitment targets and delivery milestones as the single point of accountability for detailed study start-up and monitoring plans and for delivery to the agreed plans

• As a core member of the Study Team, the SSM and will represent the CRO on matters of study execution

• Work with functional lines and directly with CRO line functions to resolve or triage site level issues

• Drive decision making and work closely with the Clinical Study Team Lead (CSTL) to provide input to operational strategy

• For studies where more than one SSM is assigned, may be required to act as ‘lead’ SSM and will coordinate activities of the other SSMs assigned

Skills and Education:

• BS/Nurse – minimum of 5 years relevant experience

• MS/PhD – minimum of 3 years relevant experience

• Extensive global clinical trial/study management experience

• Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations

• Demonstrated study management/leadership experience

• Demonstrated oversight of CROs

• Demonstrated experience in managing per subject costs, vendor and ancillary, and monitoring costs projections and spend

• Understands how to work with vendors to accomplish tasks

• Ability to interpret study level data and translate and identify risks

• Ability to proactively identify and mitigate risks around site level in study execution

• Understands feasibility of protocol implementation

• Country level cultural awareness and strong interpersonal skills

• Keen problem-solving skills

• Excellent communication skills, both written and verbal

• Must be fluent in English

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