Krutika Mane
Senior Clinical Process Associate
Summary
Highly motivated Senior Clinical Process Associate with 5+ years of experience driving efficiency and quality in complex clinical trials at IQVIA. Proven ability to manage multiple projects, ensure regulatory compliance, and mentor junior colleagues. Recognized for expertise in eTMF, and ICH GCP guidelines.
Overview
5
5
years of professional experience
Work History
Senior Clinical Process Associate
IQVIA
02.2021 - Current
- Manage complex clinical trial projects, ensuring all activities are conducted in accordance with standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements.
- Oversee the setup and maintenance of clinical trial systems (CTMS, eTMF) for assigned projects, meeting deadlines and quality standards.
- Lead the creation, management, and distribution of clinical trial documents, including reports, regulatory submissions, and essential documents (ICFs, IBs).
- Conduct comprehensive quality control reviews of clinical trial documents, identifying and resolving discrepancies.
- Collaborate with project managers, CRAs, and other stakeholders to maintain clear communication and address project challenges effectively.
- Participate in study team meetings, providing expert guidance and facilitating discussions.
- Train and mentor junior clinical process associates, fostering knowledge transfer and professional development within the team.
- Analyze clinical trial processes to identify opportunities for improvement and implement process optimization strategies.
- Stay up-to-date on current clinical research regulations and best practices.
Clinical Process Coordinator
IQVIA
02.2019 - 02.2021
- Assist with the setup and maintenance of clinical trial systems (CTMS, eTMF) in accordance with IQVIA standards and timelines.
- Create, manage, send, organize, and store clinical reports and documentation according to study protocols and regulatory guidelines.
- Participate in study team meetings and contribute to discussions as needed.
- Conduct regular quality checks of clinical trial documents to ensure accuracy and completeness.
- Assist with essential documents (Informed Consent Forms, Investigator Brochures) and regulatory submissions.
- Support study close-out activities by ensuring all documentation is finalized and archived.
- Maintain a strong understanding of ICH GCP guidelines and ensure all study activities are compliant.
- Manage workload effectively and prioritize tasks to meet deadlines.
Education
Bachelor of Science - Biotechnology
Mumbai University
Mumbai, India 04.2001 -
Skills
Records Management Expertise
Clinical Trial Knowledge
eTMF System
Inventory Management
Excellent written and verbal communication skill
Liaison Skills
Organization and Time Management
Attention to Detail
Training Skills
Leadership
Leadership
Accomplishments
2 Ovation Awards - IQVIA IMPACT PROGRAM for Support in overall collaboration, work allocation and real time support during audits and inspections.
Timeline
Senior Clinical Process Associate
IQVIA
02.2021 - Current
Clinical Process Coordinator
IQVIA
02.2019 - 02.2021
Bachelor of Science - Biotechnology
Mumbai University
04.2001 -