Sr Project Support Coord
Sr Project Support Coord
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Job Description
Work Schedule
Second Shift (Afternoons)Environmental Conditions
OfficeJob 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 redistributes the tasks based on junior PSCs 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 noncompliance to the study team and suggesting resolution.
- Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to CRGs/Client eTMF as required performing CRGs/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 setup.
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 projectspecific 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 nonclinical/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
Selfmotivated positive attitude and good interpersonal skills
Required Experience:
Senior IC
Employment Type
Full-Time
