Clinical Trial Manager - In Vitro Diagnostics

Overview:

The IVD Clinical Trial Manager works in close contact with the Functional Rep and gives input into Project Teams. They have extensive experience with Pathology lab studies. He/she is interfacing with R&D, Clinical Science, Medical Affairs, Regulatory Affairs and Biometrics in the overall design validation planning. The Clinical Trial Manager is leading the Study Team with overall accountability for study preparation, execution, and close out, thereby ensuring that the Sponsor responsibilities are fulfilled. The Clinical Trial Manager ensures that studies are conducted to meet US/EU requirements for CE and FDA approvals or any other applicable regulatory requirements.

Responsibilities:

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

• Develops study design for technical studies in coordination with internal/external experts and the development project team

• Provides input to study synopsis prepared by CST for Clinical Utility and Clinical Performance studies and ensures that these Studies are planned and executed based on study synopsis with full responsibility for study protocol and study report

• 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 and is responsible that study results are presented or submitted for publication in alignment with publication plans

• 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.

• Ensure compliance to all relevant safety and QM procedures in all studies.

Qualifications:

• 2+ year of CTM experience managing IVD clinical trials (preferred)

• Sr. or Lead CRA with extensive experience managing IVD clinical trials

• Knowledge of applicable standards and regulations for clinical trial and lab conduct

• Proven oral and written communications skills

• Experience in all stages of international clinical study management, study protocol design, report writing and monitoring and leading local teams

• Experience creating study documents (such as the ICF template, Risk Management Plan, Monitoring Plan)

• Proven planning, organizing, interpersonal and leadership skills

• Ability to work independently to make sound decisions and analyze and solve problems

• Demonstrated experience in computer skills to include Microsoft Word, Excel and basic templates

• Minimum - Bachelor's degree in medical technology, chemistry, biology or other science relevant field