Clinical Project Manager

Role Overview

• Contribute during new product development and study documentation of the assigned studies.
• Apply and comply with clinical procedures for Good Clinical Practice (GCP) and all applicable regulations for sponsored studies conducted at participating sites.
• Manage the overall process for the conduct of the program sponsored R&D External Analytical or Clinical/Performance study protocols.
• Prepare and/or review documents for submission/essential study start-up as they relate to the assigned clinical/performance evaluation studies (Clinical/Performance study protocols, Informed Consent form, Investigator Brochure, Monitoring Plan, Laboratory Manual, Clinical Site Procedures, Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant documents) in accordance with GPC, and applicable international and regional/country practices for privacy and protection of human subjects.
• Manage relationships with Investigator(s), site staff, collaborators, CRO and suppliers.
• Work cross functionally and may co-author with the R&D assigned associate writing the R&D External Analytical Study protocol(s).
• For clinical studies, develop study design, protocol draft and approval.
• Manage and/or support Ethics Review (IRB or EC) at the participating sites of the assigned study(ies).
• Monitor the Clinical study’s budget and study timeline, to ensure progress within approved parameters.
• Define, track and report schedule duration, interdependencies, milestones, critical path, efficiency and plan and staff effectiveness, and other key deliverables.
• Work cross-functionally with Core Team for site contracts, statistical analysis plan and data management to determine the data collection, recording, analysis, etc., as applicable.
• Oversee quality and content of the site staff training materials, provide input to authors for R&D External Analytical or Clinical/Performance studies, as applicable.
• Communicate effectively with internal and external partners and stakeholders, manage real and potential risks that could compromise the metrics and progress of the study.
• Draft and submit for review and approval the clinical study report(s).
• Ensures the study trial master file is complete prior to GCP quality audit.

Requirements

• Bachelor’s degree in relevant scientific discipline (Biological Sciences or Biomedical engineering focused on Biotechnology) or Advanced degree (e.g., MS, PhD, MPH, PharmD, MD) preferred.
• Minimum of 2 years of relevant industry experience in product and/or clinical development or a combination of equivalent education and experience, preferable with in-vitro diagnostics.
• Excellent verbal communication skills and ability to work effectively in a matrixial work environment required.
• Excellent written communication skills required to integrate critical documents: Protocols, Study Reports, submission packages for Institutional Review Board/ Ethics Committee review, as applicable.
• Highly organized, result and detail oriented, self-motivated with ability to take risks, willing to learn, experience with literature research method preferred.
• Working knowledge of MS Office, strong skills with MS Excel, reference management software (i.e., EndNote), PubMed/Medline and/or database development.
• Knowledge of FDA regulations, In-Vitro Device Regulation (IVDR) and General Data Protection Regulation (GDPR).

Tech Stack

• Google Cloud Platform

Benefits

• Competitive salary
• Flexible working hours
• Professional development opportunities
• Health insurance
• 401(k) matching
• Paid time off