Work Schedule
Environmental Conditions
Job Description
- Coordinates, oversees and completes functions on assigned trial 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) for self and junior PSCs, reviews and re-distributes the tasks based on junior PSC’s free capacity (in case involved in a Lead role).
- 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 and 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 and 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.
Qualifications:
Education and Experience:
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
