We are seeking a highly skilled Clinical Data Management (CDM) Lead & Training Specialist to oversee end-to-end data management activities and drive training initiatives across clinical projects. The ideal candidate should have strong leadership, technical expertise, and a passion for developing teams in a clinical research environment.

? Key Responsibilities
Clinical Data Management Leadership

Lead and manage clinical data management activities across multiple studies.

Oversee database design, CRF development, data validation, edit checks, and query management.

Ensure data quality, accuracy, and compliance with industry standards (ICH-GCP, CDISC, FDA, EMA).

Collaborate with cross-functional teams including Biostatistics, Clinical Operations, Programming, and QA.

Conduct risk evaluations and implement data-cleaning strategies to ensure high-quality deliverables.

Ensure timely database lock and submission-ready datasets.

Review and approve study documents: DMPs, DVGs, CRFs, annotation, and specifications.

Training & Development

Design and deliver training programs for CDM teams covering tools, processes, SOPs, and best practices.

Conduct onboarding and continuous capability-building sessions for new and existing team members.

Evaluate training effectiveness and implement improvements.

Develop competency frameworks, assessments, and skill-development roadmaps.

Document training activities and maintain compliance with regulatory requirements.

Clinical trials is a crucial field in the pharmaceutical industry focused on drug safety. Professionals in this area monitor, assess, and prevent adverse drug reactions to protect public health.



Qualification & Specifications :

MBBS,BDS,BHMS,BAMS,BSMS,PHARMACYB.Sc/M.Sc (Life Sciences / Biology / Bio Chemistry / Micro Biology / Nursing / Bio Technology), B.P.T, B.E BIOMEDIAL, B.Tech (Biotechnology/Bio Chemistry).

2020 -2024 passed out

Skills Required:


Scientific Background: Degree in Pharmacy, Life Sciences, or Medicine.
Attention to Detail: Meticulous accuracy in data entry and documentation.
Analytical Skills: Ability to analyze data and identify safety signals.
Regulatory Knowledge: Understanding of Good Pharmacovigilance Practices (GVP) and other regulations.
Key Responsibilities:


Case Processing: Receive, document, and process reports of adverse drug reactions (ADRs) from various sources, ensuring accurate data entry into safety databases.
Signal Detection: Analyze safety data to identify new risks or trends associated with a drug.
Risk Management: Develop and implement strategies to mitigate identified risks, ensuring the drug's benefits outweigh its potential harms.
Regulatory Reporting: Prepare and submit safety reports (e.g., PSURs) to regulatory authorities, ensuring compliance with global guidelines.
Documentation: Create and maintain accurate and compliant scientific and regulatory documents, including Standard Operating Procedures (SOPs) and safety reports.

Clinical trials is a crucial field in the pharmaceutical industry focused on drug safety. Professionals in this area monitor, assess, and prevent adverse drug reactions to protect public health.



Qualification & Specifications :

MBBS,BDS,BHMS,BAMS,BSMS,PHARMACYB.Sc/M.Sc (Life Sciences / Biology / Bio Chemistry / Micro Biology / Nursing / Bio Technology), B.P.T, B.E BIOMEDIAL, B.Tech (Biotechnology/Bio Chemistry).

2020 -2024 passed out

Skills Required:


Scientific Background: Degree in Pharmacy, Life Sciences, or Medicine.
Attention to Detail: Meticulous accuracy in data entry and documentation.
Analytical Skills: Ability to analyze data and identify safety signals.
Regulatory Knowledge: Understanding of Good Pharmacovigilance Practices (GVP) and other regulations.
Key Responsibilities:


Case Processing: Receive, document, and process reports of adverse drug reactions (ADRs) from various sources, ensuring accurate data entry into safety databases.
Signal Detection: Analyze safety data to identify new risks or trends associated with a drug.
Risk Management: Develop and implement strategies to mitigate identified risks, ensuring the drug's benefits outweigh its potential harms.
Regulatory Reporting: Prepare and submit safety reports (e.g., PSURs) to regulatory authorities, ensuring compliance with global guidelines.
Documentation: Create and maintain accurate and compliant scientific and regulatory documents, including Standard Operating Procedures (SOPs) and safety reports.

Concept Pharmaceuticals Ltd. is looking for Clinical Research Associate to join our dynamic team and embark on a rewarding career journey

As a Clinical Research Associate (CRA), you will be responsible for monitoring clinical trials and ensuring that they are conducted in accordance with regulatory requirements and ethical standards

Ensure compliance with study protocols, regulatory requirements, and ethical standardsMonitor and review study data to ensure accuracy, completeness, and compliance with study protocolsStrong knowledge of clinical research protocols, regulations, and guidelines, including ICH-GCP and FDA regulations

Proficiency in using clinical research software, such as EDC systems, and data management tools

Provides support in research and development activities, including conducting experiments, analyzing data, and collaborating with research teams. Requires background in pharmaceutical R&D and laboratory experience.