Contribute to the planning, execution, and oversight of aspects of global and/or regional clinical studies from study start-up through database lock and final CSR
Ensure timely delivery of key clinical trial deliverables and milestones, including site selection and activation, FPI, LPI, subject retention, data review, database lock, site closeout, TLF delivery, CSR, and TMF delivery
Closely oversee and coordinate vendor activities. Contribute to vendor selection and management. Act as a primary point of contact between the sponsor and CROs or vendors.
Coordinate problem-solving of vendor, site, and internal issues
Contribute to the development of clinical protocols. Review informed consent forms, case report forms, study plans and other documents for harmonization and consistency.
Comply with internal SOPs, ICH/GCP guidelines, and other regulatory requirements
Communicate study status and escalate issues to clinical management and the organization cross-functionally as required
Collaborate with internal stakeholders to ensure mutual cross-functional support to meet company objectives
Plan, prepare, and present as needed at internal and external meetings

Requirements

Bachelor's or higher degree in a scientific discipline
Minimum of 5 years of experience in clinical development with experience in clinical operations preferred
Proficiency with standard software platforms
Dedication to quality and reliability, including thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines
Strong organizational and multitasking skills
Excellent written and verbal communication and interpersonal skills.
Friendly, with the ability to develop collaborative relationships in an often remote online team environment

Benefits

90% employer-covered benefits
Flexible PTO
A very generous holiday schedule that includes a week off in August and time off around the winter holidays
A well-stocked kitchen with snacks and beverages
Additional benefits include the opportunity for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) with an employer match.
The comprehensive wellness program includes medical, dental, vision, and LTD coverage.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial managementclinical protocol developmentdata reviewvendor managementregulatory compliancestudy planningcase report form reviewsubject retention strategiesdatabase lock proceduresclinical operations

Soft Skills

organizational skillsmultitaskingwritten communicationverbal communicationinterpersonal skillsproblem-solvingcollaborationcross-functional communicationpresentation skillsrelationship building

Certifications

Bachelor's degreeICH/GCP certificationFDA regulatory training