Study Delivery Specialists

2 weeks ago


Thāne, Maharashtra, India TCS Full time
Role Description

This is a full-time on-site role as a Study Delivery Specialist located in Thane.

The Study Delivery Specialist will be responsible for managing and coordinating clinical study activities, ensuring compliance with study protocols and regulations, and facilitating communication between study teams.

The role will involve data entry, monitoring, and analysis, as well as assisting with study documentation and reporting.

Scope of work

Completion and maintenance of internal systems/databases/tracking tools and project plans (CSAP)TMF ManagementSupporting the study team in global study coordination activitiesBudget managementKey contributor to Inspection readinessPreparation and update of study documents and study plansVendor ManagementCountry OversightRisk ManagementClinical Supplies oversight and recruitment materials management

Apply only if you have experience on above activities and having qualifications as below.

Qualifications


Candidate should be Pharma or life science graduate with 5-10 years of experience in Clinical Operations which must include 3-5 years of CRA experience.

Good knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelinesStrong organizational and project management skillsAbility to manage multiple competing priorities within various clinical trials with good planning, time management and prioritization skillsQuality mindset, critical sense, attention to details.

Promotes a total quality cultureGood understanding of the principles of project planning & project managementProven negotiation and influencing skills and effective at conflict resolutionAttention to detail and ability to follow protocolsExcellent communication and interpersonal skillsProficiency in data entry and analysisExperience in clinical research or a related fieldKnowledge of regulatory requirements and guidelinesAbility to work effectively in a team environmentTools knowledge like Microsoft office (Excel, PowerPoint, Word, Outlook, etc.)

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