Associate/ Clinical Project Manager at IQVIA

Bangkok, Bangkok, Thailand

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalsIndustries

Requirements

Bachelor degree in related discipline, preferably in Life Science, or equivalent qualification
Experience in Clinical project management with prior monitoring background
Good knowledge of international guidelines ICH-GCP as well as relevant local regulations
Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality
Excellent project management skills
Excellent team building and interpersonal skills
Excellent organisational skills
Excellent verbal and written communication skills
Excellent ability to prioritize and handle multiple tasks

Responsibilities

Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality
Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies
Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with sponsor’s Procedural Documents, ICH-GCP and local regulations
Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality
Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks
Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study
Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations
Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head)
Ensures timely preparation of local Master CSA (including site budget) and amendments as needed
Ensures that all study documents are ready for final archiving and completion of local part of the eTMF
Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA

Skills

Key technologies and capabilities for this role

ICH-GCPClinical Trial ManagementSite SelectionSite Qualification VisitsRegulatory SubmissionsEC/IRBStudy Budget ManagementTeam LeadershipCRA ManagementCSA ManagementeTMFAuditsRegulatory Inspections

Questions & Answers

Common questions about this position

What qualifications and experience are required for the Associate/Clinical Project Manager role?

A Bachelor degree in a related discipline, preferably in Life Science or equivalent qualification is required, along with experience in clinical project management with prior monitoring background.

What key skills are needed for this position?

Candidates need good knowledge of ICH-GCP and local regulations, proven ability to lead and motivate cross-functional teams, excellent project management skills, team building and interpersonal skills, organizational skills, verbal and written communication skills, and ability to prioritize multiple tasks.

What is the salary or compensation for this role?

This information is not specified in the job description.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What does the company culture or work environment look like at IQVIA?

This information is not specified in the job description.

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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