SENIOR MANAGER Job Details

Job Description

Job Title: SENIOR MANAGER

Posting Start Date: 9/9/26

Job Description:

Company Overview

Role Purpose

The Senior Specialist – Clinical Trial Management is responsible for overseeing the planning, execution, and delivery of global or regional clinical trials in alignment with regulatory, ethical, and company standards. This role ensures that clinical studies are executed on time, within budget, and with the highest quality and compliance. The position collaborates cross-functionally with clinical teams, vendors, investigators, and regulatory bodies to manage study timelines, resources, site relationships, and operational risks. It plays a critical role in the successful execution of clinical development plans that support product approval and lifecycle management.

Academic Stream

PHARMACEUTICAL SCIENCES

Work experience (in months)

Job Responsibility and key Decisions

Study StartUp and Site Activation

Manage essential activities such as feasibility assessments, site selection, ethicsIRB submissions, regulatory document collection, and site initiation.

Trial Operations Oversight

Oversee the daytoday operations of the clinical trial, ensuring milestones FPFV, LPLV, database lock are achieved according to plan.

Stakeholder Coordination

Serve as the operational point of contact for internal teams, vendors, and investigational sites throughout the study duration.

Monitoring and Quality Oversight

Coordinate and oversee CRA activities, monitor performance, and ensure timely resolution of site issues, deviations, and protocol violations.

Risk and Issue Management

Identify operational risks early, develop mitigation plans, and ensure escalation and documentation per SOPs.

Budget and Vendor Management

Support the creation and tracking of study budgets, manage invoices, and ensure vendors are meeting expectations on deliverables and timelines.

eTMF and Documentation Maintenance

Ensure timely and accurate document upload and maintenance in the eTMF ensure audit readiness at all times.

Training and Compliance Support

Ensure site personnel and vendor teams are trained per protocol and SOPs support internal QA and inspection preparation.

Study CloseOut Activities

Manage clinical site closeouts, ensure complete data collection and archiving, and contribute to final study reporting activities.

Performance Reporting

Generate operational metrics, dashboards, and regular updates to management on study progress, risks, and key decisions.

Key Decisions

Site and Vendor Selection

Recommend and approve final sites and vendors based on feasibility, performance history, and study requirements.

Protocol Amendment Implementation

Lead implementation of protocol amendments and determine their operational impact on timelines, costs, and site retraining.

Issue Escalation and Resolution

Decide when and how to escalate operational issues e.g., safety concerns, noncompliance, delays and recommend corrective actions.

Resourcing and Budget Adjustments

Make informed decisions on resource allocation and budget reforecasting based on changes in enrollment or scope.

Monitoring Strategy Adjustments

Recommend changes to monitoring plans based on trial complexity, site performance, and risk assessment.

Vendor Oversight Actions

Take corrective actions with vendors or CROs not meeting KPIs, including retraining, escalation, or termination if necessary.