Sr. Project Support Coordinator

4+ years

Not Disclosed

Remote

10 Sept. 11, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Work Schedule:
Flexible/Other

Environmental Conditions:
Office-based

Job Description:

Coordinates, oversees, and completes assigned trial activities as outlined in the task matrix.
Conducts department, internal, country, and investigator file reviews as assigned, documenting findings, following up for resolution, and escalating issues when necessary.
Ensures tasks are completed on time, within budget, and at a high-quality standard. Identifies variances (overburn/underburn) and adjusts task distribution for self and junior PSCs based on workload.
Supports the maintenance and oversight of study-specific documentation, including global support with systems, tools, and trackers. This includes managing study team lists, tracking project-specific training requirements, system access for organizations/vendors/clients, and monitoring project-level activity plans.
Provides system support (CTMS, Oracle Activate & eTMF), managing access requests, monitoring study-level documents, ensuring audit readiness, addressing non-compliance, and proposing resolutions to the study team.
Performs administrative tasks such as processing documents, conducting eTMF reviews, coordinating issue resolution, managing mass communications, and providing reports to internal team members.
Schedules and organizes client and internal meetings, including preparation and distribution of meeting minutes and follow-up on action items.
Exports, reconciles, and analyzes study metrics reports, identifying potential issues, particularly when involved in a Lead role.
Maintains vendor trackers and ensures accuracy.
Coordinates and compiles Investigator Site Files (ISF) templates and pharmacy binders under the guidance of the Clinical Team Manager.
Attends Kick-off and Project Launch meetings, taking notes and supporting study setup when required.

Education and Experience:

High school/secondary school diploma or equivalent, with relevant formal academic or vocational qualifications.
Technical positions may require certification.
A minimum of 4 years of experience in a similar role.

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Sr. Project Support Coordinator

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