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We know just how important it is to put people first. It's with that human touch that we've played a part in nearly all of the top 50 treatments on the market. And every day, we're focused on working with industry leaders to bring life-changing healthcare to patients across the globe. Whether you join our Clinical, Consulting, Biotech, Functional Service Provider (FSP), or other teams, we're doing it With Heart ™.

Senior Study Manager - FSP - Home-Based in US or Canada

Job ID R0000006047 United States of America - Remote - Southeast

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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


#LI-REMOTE

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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