Job Description

Duties & 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.

Requirements:

University degree in life sciences or related field

At least 6 years\xe2\x80\x99 experience in clinical research (2 years in project management), preferably in the Pharmaceutical/CRO Industry.

Prefer to having 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).

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible \xe2\x80\x93 to help our customers create a healthier world. Learn more at

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