Global Study Manager Job

GLOBAL STUDY MANAGER needed for a CONTRACT opportunity with Yoh's client located in Indianapolis, Indiana.

The Big Picture - Top Skills You Should Possess:

- Leads the global study team with full accountability for the study with respect to quality, cost and timelines.

What You'll Be Doing:

- Develops study design in coordination with internal/external experts and the development/project team; ensures that global design validation plans are available for design validations/performance evaluations and clinical studies developed in cooperation with internal/external experts and agreed upon with the LCT project team.
- Close cooperation with Regulatory affairs to support pre- submission process.
- Ensures that all studies are planned, executed, monitored, closed out and documented in a competent and compliant way within the planned time frame and costs.
- Ensures that the study results are continuously validated, assessed, clear recommendations drawn and communicated.
- Oversight of data management processes, data quality and results, data base closure and reporting.
- Ensures that data and reports which are necessary for the characterization, regulatory approval and marketing of the products have been agreed upon, made available and are documented in a timely fashion.
- Ensures that the results of the studies are presented according to the agreed publication plan eg in workshops, publications and other printed medias.
- Planning of the study specific content and budget within the development/project team and controlling the related agreed upon budgets during the study.
- Managing study site and clinical study agreements.
- Delegation and oversight of tasks and work packages for internal and external collaborators within the study.
- Planning, procurement, preparation and delivery of materials necessary for carrying out the study, in cooperation with the Study Support team.

What You Need to Bring to the Table:

- Bachelor's required
- Ensure compliance to all relevant company safety and QM procedures in all studies.
- Accountable for site selection in collaboration with Global Monitoring, oversight of site assessment and qualification, establishment of a trustful relationship to the external site personnel.
- Provide scientific and clinical operations project management expertise to cross-functional teams (eg CDT, PTs, assay development).
- Prepare study protocol in a coordinated manner with internal and external experts.
- Organizational set up of the study in cooperation with global monitoring, supervision of coworkers in Matrix organization, continuous assessment of the results and immediate communication especially in case of unexpected observations.
- Preparation of a study report including recommendations and corrective actions.
- Initiate contacts and develops relationship with international experts, KOLs, principal investigators and customer groups to use the external know-how for the development of new products and to support acceptance of new products.
- Ensures in fully or partially outsourced studies CRO oversight.
- Continuous follow up on market developments and competitor products.
- Regular feed-back to Site Head Monitoring on study progress, issues and performance of CRAs.
- Provides study conduct expertise during interaction with regulatory authorities.
- Responsibility to ensure compliance with safety regulations and their subject-specific translation into procedures for Professional Diagnostics - Clinical Operations. Give input into ClinOps Q documents based on study specific experiences

GET HIRED, APPLY NOW!

RECRUITER: Jerrod Macias

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: SCIENTIFIC

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