Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Central Review Manager – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed, aids the development of site activation, and develops collaborative relationships with investigators and site personnel. Supports training of new staff and participates in departmental initiatives to aid in process improvements/enhancements.
What You’ll Do:
- According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
- Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.
- Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.
- Supports the maintenance of study specific documentation and systems including but not limited to: study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans in appropriate system.
- Provides system support (i.e. Activate & eTMF) ).
- Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
- Supports scheduling of client and/or internal meetings.
- Reviews and tracks local regulatory documents.
- Transmits documents to client and centralized IRB/IEC.
- Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
- Maintains vendor trackers.
- Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
- Assists with study-specific translation materials and translation QC upon request.
Education, Experience and Requirements:
- Bachelor's degree or higher in Lifesciences.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
Knowledge, Skills, Abilities:
- Ability to work in a team or independently as required
- Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
- Strong customer focus
- Flexibility to reprioritize workload to meet changing project timelines
- Proven ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout
- Good English language and grammar skills and proficient local language skills as needed
- Advanced digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
- Ability to successfully complete PPD clinical training program
- Self-motivated, positive attitude and good interpersonal skills