Clinical Trial Manager - Iqvia Biotech

Collinson; Gauteng; On-site; ZAR 600 000 - 800 000; Full time

Job summary

A leading clinical research organization is hiring a Clinical Trial Manager in Gauteng. The role involves leading clinical trial delivery, ensuring compliance with regulatory requirements, and managing project finances. Candidates should have a Bachelor's Degree in a relevant field and at least 2 years of experience in clinical trial management. Strong project management skills and knowledge of ICH and GCP guidelines are essential.

Qualifications

• Minimum 2 years of experience in clinical trial management or related experience.
• Good understanding of ICH and GCP guidelines.

Responsibilities

• Lead clinical trial delivery and manage project team.
• Ensure compliance with regulatory requirements.
• Develop project risk mitigation plans.
• Manage clinical finances and stakeholder relationships.

Skills

Clinical trial management

Project management

Regulatory requirements knowledge

Effective communication

Stakeholder management

Education

Bachelor's Degree in health care or scientific discipline

Job description

Overview

Job title : Clinical Trial Manager - IQVIA Biotech

Job Location : Gauteng, Centurion

Deadline : November 22,

Clinical Trial Managers (CTM) are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients' lives by bringing new drugs to the market faster.

The CTM is a member of the core project team responsible for clinical delivery of full service, large, multi-regional studies to meet contractual requirements and in accordance with SOPs, policies and practices.

Ensure clinical delivery of assigned projects in compliance with regulatory requirements (ICH-GCP, protocol), customer requirements (contract), and internal requirements (policies, SOPs, project plans).

Accountable for meeting projects' recruitment targets and ensuring appropriate recruitment strategies are in place.

Contribute to the development of the project risk mitigation plan.

Manage clinical risks through the project lifecycle.

Ensure clinical quality delivery by identifying quality standards / requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.

Manage clinical aspects of Project Finances including Estimate at Completion (EAC).

Understand the scope of clinical delivery and create plans to deliver.

Monitor and manage changes against baseline EAC and identify additional service opportunities or out of scope work.

Work as the primary CTM alongside other CTMs to deliver large, global trials.

Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.

Collaborate with the clinical team to support milestone achievements.

Report to internal and external stakeholders as per project scope requirements.

Resourcing and Talent Planning of the clinical team.

Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.

Conduct regular team meetings and communicate appropriately to achieve objectives.

Support professional development by providing feedback to clinical team line managers on performance relative to project tasks to support professional development.

Adopt corporate initiatives and changes and serve as a change advocate when necessary.

May contribute to the development of the clinical delivery strategy for business proposals.

Participate in bid defense preparations and meetings.

Develop and present Clinical Operation plan in partnership with Business Development and Project Leadership.

May mentor and coach new peers as they assimilate into this role.

May attend site visits as applicable in support of project delivery.

Qualifications

Bachelor's Degree in health care or other scientific discipline required

Experience

Ideally at least 2 years experience in clinical trial management or equivalent combination of education, training and experience.

Requires consolidated knowledge of Project management practices and terminology.

Requires good knowledge of applicable clinical research regulatory requirements i.e., GCP and ICH guidelines.

Requires broad protocol knowledge and therapeutic knowledge.

Req

Requires good understanding of Clinical Research industry (drug / device / technology / etc.) and the relevant environments in which it operates.

Requires understanding of project finances.

Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH and GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.