Senior/Clinical Project Manager

IQVIA; Kuala Lumpur; On-site; MYR 150,000 - 270,000; Full time

Job summary

IQVIA in Kuala Lumpur seeks a Project Lead to drive clinical study delivery in line with contract requirements and SOPs. The role involves leading core project teams, managing study scope and quality, and coordinating with clinical and business development teams to meet milestones and customer expectations.

The successful candidate will have a life sciences degree, 5+ years of relevant experience including project management, and strong English communication and leadership skills to guide teams

Qualifications

• Bachelor's degree in life sciences or related field.
• 5 years of relevant experience including 1+ year project management experience.
• Knowledge of clinical trials and regulatory requirements (ICH GCP) and local regulations.
• Strong written and verbal English communication and presentation skills.
• Ability to lead cross-functional teams and manage contracts, scope, and quality.

Responsibilities

• Participate in bid defense presentations with Business Development; may lead for smaller regional studies.
• Deliver and manage smaller, regional studies per contract with focus on speed, quality, and cost.
• Develop integrated study management plans with the core project team.
• Manage study execution, ensure adherence to SOPs, and monitor project risk and issues.
• Lead cross-functional collaboration to achieve milestones and customer satisfaction.
• Forecast revenue opportunities and manage change controls as needed.
• Provide input on team performance and mentor junior staff.

Skills

Communication skills

Presentation skills

Problem solving

Leadership

Education

Bachelor's Degree Life sciences or related field

Job description

Job Overview

Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients' lives by bringing new drugs to the market faster. The Project Lead is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices. Clinical Project Management is focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction. Clinical Project leads can run their own studies. The Project Lead focus is on leveraging therapeutic expertise and IQVIA's suite of solutions to drive operational excellence and strategic leadership with our customers.

Essential Functions

• Participate in bid defense presentations in partnership with Business Development and may lead the presentation for smaller, less complex regional studies.
• May be responsible for delivery and management of smaller, less complex, regional studies.
• Develop integrated study management plans with the core project team.
• Accountable for the execution of clinical studies, or assigned portion of clinical studies, per contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
• Set objectives of the core project team and/or sub-team(s) according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
• Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
• Monitor progress against contract and prepare/present project and/or sub-team information proactively to stakeholders internally and externally.
• Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.
• Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans.
• May serve as primary or backup project contact with customer and would then own the relationship with the project's key customer contacts, as well as communicate/collaborate with IQVIA business development representatives, as necessary.;
• Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.;
• Ensure the financial success of the project.
• Forecast and identify opportunities to accelerate activities to bring revenue forward.
• Identify changes in scope and manage change control process as necessary.
• Identify lessons learned and implement best practices.
• May be assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.;
• Adopt corporate initiatives and changes and serve as a change advocate when necessary.
• Provide input to line managers of their project team members' performance relative to project tasks.
• Support staff development and mentor less experienced project team members on assigned projects to support their professional development.

Qualifications

• Bachelor's Degree Life sciences or related field.
• 5 years of prior relevant experience including > 1 years project management experience or equivalent combination of education, training and experience.
• Advanced knowledge of job area, and broad knowledge of other related job areas, typically obtained through advanced education combined with experience.
• Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge; therapeutic knowledge desired.;
• Communication - Strong written and verbal communication skills including good command of English language. Strong presentation skills.
• Problem solving - Strong problem solving skills.
• Leadership - Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross functionally and with customers to advance work effectively and efficiently.
• Leadership - Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
• Organisation - Planning, time management and prioritization skills. Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in adv