Sr Study Manager (Single Sponsor Dedicated) - Netherlands (Home Based)

---

Job description

Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. We bring together more than 25,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients' lives around the world.

For our client, a global pharmaceutical organization we are currently looking for a *Sr Study manager.* In this role you will be working homebased in Netherlands.

The Study Manager has responsibility for 1 or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies. The Study Manager leads and manages the tactical execution of one or more clinical studies from study startup through database release.

The Study Manager provides quality oversight to the Contract Research Organization (CRO) and of the CRO deliverables related to study execution. The Study Manager 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. The Study Manager will 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.

The Study Manager is a core member of the Study Team and will represent the CRO on matters of study execution. The Study Manager works with functional lines and directly with CRO line functions to resolve or triage site level issues. The Study Manager will drive decision making and work closely with the Clinical Project Manager to provide input to operational strategy. 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.

* Organizational Relationships *

* In addition to responsibilities for working with other Study Managers, the Senior Study Manager will be responsible for liaising with members of the project team to include but not limited to: Clinical Study Team Lead (CSTL), Supply Chain Coordinator (SCC), Lead Data Manager (LDM), CPW Lead, Clinician, C&O, U.S. region and PCO CPMs.
* Will also liaise with Clinical Study Team Lead (CSTL), Asset Lead or Clin Ops Study Team Lead for technical system and process expertise and TA operational knowledge.

* Primary Duties *

* Operational Study Management for 1 or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies: *

* Accountable for the development of realistic detailed study startup and monitoring plans
* Accountable for conducting country level feasibility in collaboration with Global Clinical Trial Execution and CROs, reviewing Pre-trial Assessment outputs, approving sites, and assessing site activation plans
* Leads study risk planning process in context of site and subject
* Coordinates study/protocol training & investigator meetings
* Develops and provides key inputs to Clinical Trial Budget (e.g., Per Subject Costs)
* Accountable for the delivery of the study against approved plans
* Leads inspection readiness activities related to study management and site readiness
* May produce or review model Informed Consent Document (ICD) and study/country/site level ICD, as appropriate
* May expand study design document into approved protocol template while incorporating input from other team members (e.g., Clinician, Clinical Pharmacology Lead, Supply Chain Lead, Statistician, Outcomes Research Representative, Clinical Assay Group, etc.)

* Study Management Oversight: *

* Approves the Study Startup, Study Monitoring & protocol recruitment plans
* Approves & oversees drug supply management - manages flow of drug supply to the sites & set up Interactive Voice Randomization System with Supply Chain Lead
* Reviews consolidated Pre-trial assessment reports, feasibility outputs, etc.
* May support study level submission readiness

* Study Team Interface: *

* Leads and oversees all elements of study startup and monitoring functions both internally and at the CROs to ensure delivery & compliance with all applicable Standard Operating Procedures (SOPs) and Quality Standards, interfacing directly with CRO to determine Feasibility / Study Startup, Monitoring / Management & Site Contracting Groups
* Works proactively with CRO and data management functions to ensure alignment on data flow and timely delivery
* Shares and escalates plan deviations to Clinical Project Manager (and study team)
* Provides ongoing assessment of subject enrollment / discontinuations to inform accurate forecasting for financial planning
* Provides operational input into protocol design

* Subject Matter Expertise: *

* The Study Manager will be the technical expert for study management systems and processes
* The Study Manager will champion the implementation and use of harmonized, consistent processes and excellence in Study Management deliverables related to cost-effective, timely, and high-quality clinical trial data according to agreed global goals.
* The Study Manager will be responsible for the technical oversight of the CRO to include but is not limited to: mentoring, standards, continuous improvement, issue escalation/resolution, inspection readiness/quality assurance, performance feedback, review of metrics.
* The Study Manager partners with CRO Managers to proactively identify and resolve study operations staff performance issues.
* For project-specific audits and inspections, the Study Manager can serve as a resource to the study team to facilitate the audit/inspection.
*The ideal candidate has:*

*Qualifications*

*Training and Education Preferred*:

* Extensive global clinical trial/study management experience

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

* BS/Nurse - minimum of 5 years relevant experience

* MS/PhD - minimum of 3 years relevant experience

*Prior Experience Preferred*:

* Demonstrated study management / leadership experience

* Demonstrated oversight of CROs

* Demonstrated experience in managing Per Subject Costs, vendor & ancillary, and monitoring costs projections & spend

*Skills:*

* Understands how to work with vendors to accomplish tasks

* 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

* Country level cultural awareness and strong interpersonal skills

* Keen problem-solving skills

* Excellentcommunication skills, both written and verbal. Must be fluent in English.

* Detail oriented & possesses technical expertise (e.g., spreadsheets, metrics & data flow management)

*Get to know Syneos Health*

We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

*Additional Information:*

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

#LI-EW1