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Suma Soft
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Clinical Trial Team Lead

Clinical Trial Team Lead

Suma Soft

4 - 8 years

2 - 7 Lacs

pune

Posted:3 weeks ago| Platform:

Apply

Skills Required

medidata rave edc crf clinical data management clinical trials

Work Mode

Work from Office

Job Type

Full Time

Job Description

Desired Candidate Profile:

6+ years of experience in clinical research, with at least 2 years in a leadership role.
Strong understanding of clinical trial methodology and regulatory landscape (DCGI, ICH-GCP, etc.)
Experience in managing multi-site studies in India and/or global trials.
Excellent communication, organizational, and project management skills.
Ability to lead cross-functional teams and manage multiple priorities.
Proficient in CTMS, EDC systems, and MS Office tools.

Clinical Trials Team Lead

Key Responsibilities:

Lead and manage the clinical trial team across multiple sites and phases.
Coordinate protocol development, site selection, and ethics submissions.
Oversee study start-up, monitoring, data collection, and close-out activities.
Ensure compliance with ICH-GCP guidelines, regulatory requirements, and SOPs.
Communicate with investigators, sponsors, vendors, and cross-functional teams.
Manage timelines, budgets, and risk assessments for clinical projects.
Review monitoring reports and support CRAs in resolving site issues.
Provide training, mentorship, and performance feedback to team members.

Desired Candidate Profile:

6+ years of experience in clinical research, with at least 2 years in a leadership role.
Strong understanding of clinical trial methodology and regulatory landscape (DCGI, ICH-GCP, etc.)
Experience in managing multi-site studies in India and/or global trials.
Excellent communication, organizational, and project management skills.
Ability to lead cross-functional teams and manage multiple priorities.
Proficient in CTMS, EDC systems, and MS Office tools.

How to Apply / Contact Information

Interested candidates can apply or reach out for more information by contacting:

HR Contact:

Email:

Phone:

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