Join Us as aProject Support Coordinator – 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.
As part of our global team, you’ll have the opportunity to independently provide administrative and technical support to project teams, including planning, organizing, and coordinating responsibilities at a global level. As a Project Support Coordinator, you'll drive and coordinate the initial study setup, ongoing maintenance of various systems, complete data entry, and maintain database repositories. You will prepare reports, collect data for analysis and reviews, and support audit readiness by ensuring files are reviewed on schedule, as detailed in the organization's SOPs/Client specific guidance document. You will contribute to the risk management process by timely identification and escalation of issues. You will support functional group and cross-functional initiatives for process improvements and enhancements. You may act as a main point of contact with the Project Lead (PL) or Clinical Team Manager (CTM) and provide oversight and coordination support to junior PSCs whenever required.
What You’ll Do:
- 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. Follows up for resolution of findings and escalates whenever necessary.
- Ensures allocated tasks are performed on time, within budget and to a high quality standard. Escalates in cases of variances (overburn/underburn).
- Supports the maintenance and oversight of study specific documentation and global support with specific systems, tools and trackers including, but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system.
- Provides system (i.e. CTMS, Oracle Activate & eTMF) support by managing the access requests, tracking study level documents, maintaining audit readiness, communicating the non-compliance to the study team and suggesting resolution.
- Performs administrative tasks on assigned trials including, but not limited to: timely processing of documents sent to CRG's/Client eTMF as required, performing CRG's/Client eTMF reviews, coordinating and proposing issue resolution, performing mass mailings and communications as needed, providing documents and reports to internal team members.
- Supports scheduling and organization of client and/or internal meetings with completion and distribution of related meeting minutes and follow up for closure of action items, if required.
- Exports and reconciles study metrics reports, and if required analyzes and identifies issues (if involved in a Lead role).
- Maintains and regularly checks for correctness of vendor trackers.
- Drives and coordinates the compilation of Investigator Site File (ISF) template, pharmacy binder with instruction from the Clinical Team Manager.
- Attends Kick off and Project Launch meetings and takes notes when required, supports initial study set-up.
Education and Experience Requirements:
- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
- Technical positions may require a certificate
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Ability to work in a team or independently as required
- Strong organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
- Strong customer focus
- Excellent time management skills. Demonstrated flexibility to reprioritize workload to meet changing project timelines
- Demonstrated ability to attain and maintain a good working knowledge of applicable Country
- Regulations (if required), ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout
- Excellent English language and grammar skills and proficient local language skills (if required).
- Effective oral and written communication skills with the ability to communicate effectively with project team members
- Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain
- knowledge and learn the required clinical trial systems. Good presentation skills.
- Ability to successfully complete CRG training program
- Self-motivated, positive attitude and good interpersonal skills
Working Conditions and Environment:
- Work is performed in an office or clinical environment with exposure to electrical office equipment.
- Occasional drives to site locations. Potential Occasional travel required.
