Clinical Trial Manager (12-month contract) at IQVIA

Singapore

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceutical, CROIndustries

Requirements

University degree in life sciences or related field
At least 6 years’ experience in clinical research (2 years in project management), preferably in the Pharmaceutical/CRO Industry
Prefer to have experience of project management
Highly developed project management and team leadership capability, ability to work independently and as part of a team
Excellent communication and interpersonal skills
Structured mindset, good scientific, medical and analytical thinking
Highly committed to timelines and delivery of maximum quality data
Full and permanent awareness of ethical responsibility inherent to research involving human subjects
Good knowledge of the Clinical Development process including the regulatory requirements
Good English language skills (spoken and in writing)
Prompt responsiveness, outstanding ability to cope with multiple requests and to work under time pressure
Proficiency in all common office software and smooth self-training of new software programmes (user)

Responsibilities

Leads the local/regional trial team in the capacity of Clinical Trial Manager (CTM) during trial preparation, conduct and close-out
Selected sites conduct and deliver the trial according to the clinical trial protocol, within trial timelines, and in compliance with ICH-GCP and all other relevant external regulations
Lead and support local trial team and investigative sites in timely preparation of required trial documents, contracts and necessary approvals
All Regulatory Requirements are satisfied prior to trial/site initiation
Set up, manage and review trial budget to ensure appropriate level of financial oversight. Timely budget updates based on trial changes
Ensure appropriate trial-specific training of internal and external partners in line with Trial Training Plan
In collaboration with Site Monitoring Lead and CRAs, ensure a) provision of appropriate trial oversight for the trials by monitoring compliance of trial sites and team to GCP, local regulations, SOPs, and adherence to trial protocol; b) adequate trial supply distribution to sites; c) continuous and timely data entry and cleaning, and on time Data Base Lock
Trial contact for CRAs, investigators and site staff
In collaboration with Trial Record Specialist and with supports from CRAs as appropriate, ensures collection of required documents, with timely, complete and compliant archiving of all relevant documents for the eTMF and CTR Appendices
Ensures all tasks are carried out in accordance with respective applicable SOPs, Business Practices and regulatory requirements. Ensures that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with Values

Skills

Clinical Trial Management

Project Management

ICH-GCP

Regulatory Compliance

Trial Budgeting

Site Monitoring

CRA Oversight

eTMF Management

SOP Compliance

Data Cleaning

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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