Detailed Flowchart of Cros
Detailed Flowchart of Cros
The transition from Clinical Research Coordinator (CRC) to Clinical Data Manager (CDM) in Clinical
Research Organizations (CROs) involves a step-by-step progression where you need to build new
skills, acquire deeper knowledge of data management, and gain more experience in handling clinical
trial data. Below is a detailed flowchart with role responsibilities, skills needed, suggested actions,
and salary progression at each stage for each role in the CROs based in Hyderabad, Chennai, and
Bangalore.
Role Responsibilities:
Coordinate with study investigators, site staff, and clinical research associates (CRAs).
Skills Required:
Suggested Actions:
Get involved in data collection and entry, understand the role of data management teams.
Participate in cross-functional team meetings with CRAs, data managers, and statisticians.
Role Responsibilities:
Verify that data from CRCs and sites are compliant with protocol.
Ensure data consistency and validity in Electronic Data Capture (EDC) systems.
Skills Required:
Proficiency in using EDC systems and clinical trial databases (e.g., Medidata, Oracle Clinical).
Ability to communicate with CRCs and other stakeholders about data-related issues.
Suggested Actions:
Take training or certification in Clinical Data Management (CDM) and EDC systems.
Start learning about data cleaning and data quality control procedures.
Start reviewing and cleaning datasets, and learn how to resolve data queries.
Junior Data Manager Salary (2-3 years): ₹5,00,000 - ₹7,00,000 per annum.
Role Responsibilities:
Oversee the data collection process from multiple clinical trial sites.
Collaborate with CRAs, investigators, and CDMs to ensure data is accurate and up-to-date.
Prepare datasets for statistical analysis, ensuring compliance with regulatory standards (e.g.,
CDISC).
Skills Required:
Advanced proficiency in EDC systems (e.g., Medidata, Oracle Clinical, Veeva Vault).
Strong understanding of data cleaning, validation, and data query resolution.
Suggested Actions:
Take certifications in Certified Clinical Data Manager (CCDM) or GxP data management.
Familiarize yourself with data management plans and regulatory requirements for data
submission.
Clinical Data Coordinator Salary (2-4 years): ₹6,00,000 - ₹8,00,000 per annum.
Senior Data Coordinator Salary (4-5 years): ₹8,00,000 - ₹10,00,000 per annum.
Role Responsibilities:
Lead and manage the entire data management process for clinical trials.
Oversee database locking and final dataset preparation for statistical analysis.
Collaborate with clinical, regulatory, and statistical teams to ensure data quality and integrity.
Ensure compliance with regulatory standards, industry guidelines, and data management
best practices.
Skills Required:
Suggested Actions:
Take advanced certifications such as Certified Clinical Data Manager (CCDM) or Clinical Data
Management Master’s program.
Lead or manage small data teams to gain leadership experience.
Network with other CDMs to stay updated on industry trends and best practices.
[CRC] (Fresher)
- Data entry, site coordination, participant management, and basic data documentation.
- Assist with data entry, data validation, and basic query management.
- Oversee data verification, resolve queries, prepare data for statistical analysis.
- Learn data management standards (CDISC, SDTM), collaborate with cross-functional teams.
- Lead the entire data management process, ensure regulatory compliance, manage data teams.
Skills Development: As you transition from CRC to CDM, the biggest shift is from site-based
data collection to managing and overseeing the data lifecycle. Focus on learning data
management systems (like Medidata, Oracle Clinical, Veeva Vault) and acquiring
certifications in CDM and GxP to validate your expertise.
Certifications: Pursuing certifications like Certified Clinical Data Manager (CCDM) or Clinical
Data Management Master’s program will significantly boost your credibility and knowledge.
You can also look into specific training in EDC systems, clinical data standards (CDISC), and
regulatory guidelines.
Networking and Mentorship: Seek out mentors within your organization or in professional
organizations (e.g., DIA India, ACRP) who can guide you through the transition process.
Networking with other professionals can also help you stay updated on industry trends.
Salary Growth: As you transition through the stages, the salary progression grows
significantly, especially once you reach the Clinical Data Manager role. Senior-level roles in
data management can see salaries upwards of ₹20,00,000 per annum, particularly in top-tier
CROs.
By following these steps and focusing on continuous learning and skills development, you can
successfully transition from a Clinical Research Coordinator (CRC) role to a Clinical Data Manager
(CDM) role, with solid career progression and salary growth in leading CROs across Hyderabad,
Chennai, and Bangalore.
India is home to many leading Clinical Research Organizations (CROs) that provide a wide range of
services, including clinical trial management, regulatory affairs, data management,
pharmacovigilance, and more. Below is a list of prominent CROs located in Hyderabad, Chennai, and
Bangalore, along with a brief description of each organization.
1. Syneos Health
o Focus: Full-service global CRO offering drug development and commercial solutions.
o Services: Clinical trials, data management, regulatory affairs, patient recruitment,
and market access.
3. PAREXEL
o Services: Phase I-IV clinical trials, data management, biometrics, and regulatory
services.
5. Medpace
o Focus: Full-service global CRO that provides comprehensive clinical trial services.
6. Celerion
7. Pharmalex
8. ClinTec International
1. PAREXEL
2. Pharmalex
o Focus: Provides technology and consulting services for clinical trials and data
management.
4. Medpace
o Focus: Provides clinical trial management services for the pharmaceutical and
biotechnology industries.
6. ClinTec International
o Focus: Full-service CRO providing clinical research services across a wide range of
therapeutic areas.
7. GCP Global
o Focus: Specializes in clinical trials, clinical data management, and GCP compliance
services.
9. Veristat
10. KCR
o Focus: Full-service CRO with expertise in clinical trials, regulatory affairs, and clinical
data management.
o Focus: Provides technology and consulting services to support clinical trials and data
management.
2. Syneos Health
o Focus: Global CRO offering end-to-end solutions for clinical trials and
commercialization.
o Focus: Full-service CRO with expertise in clinical trials and laboratory services.
4. Medpace
o Focus: Full-service CRO offering comprehensive Phase I-IV clinical trial services.
5. Parexel
7. Pharmalex
8. GVK Biosciences
9. Biostat
o Focus: Full-service global CRO providing clinical trial services for the pharmaceutical
and biotechnology industries.
Starting with internships or entry-level roles is a great way to gain hands-on experience. These
positions are designed for freshers and offer the opportunity to learn on the job. Some typical entry-
level positions include:
Clinical Data Coordinator (CDC): In this role, you would be responsible for assisting in data
collection, ensuring data quality, and managing data entry from clinical trial sites.
Data Management Associate: Involves assisting senior data managers with data collection,
data entry, cleaning, and verification tasks.
Clinical Research Assistant/Clinical Trial Assistant: While this role is more general, it may
involve supporting the clinical data management team with administrative tasks, data entry,
and document preparation.
Junior Clinical Data Manager: Some companies offer positions as "junior" or "assistant" data
managers for freshers, allowing you to grow within the field.