Avance Clinical is a leading Contract Research Organisation (CRO) that specializes in supporting drug development for the pharmaceutical and biotechnology industry. With a rich history dating back to the 1980s, Avance Clinical is renowned for its expertise in clinical data management and drug development. The company focuses on fostering a fun, friendly, and flexible work environment that values honesty, respect, and team spirit. Avance Clinical is committed to supporting its employees in balancing their work commitments and personal needs.
Job Description: Clinical Data Manager
Avance Clinical is seeking a Clinical Data Manager I (CDM I) to join their dynamic team in Bengaluru, Karnataka. As a Clinical Data Manager, you will play a pivotal role in ensuring that clinical trials are conducted in compliance with protocols, Standard Operating Procedures (SOPs), ICH GCP guidelines, and other applicable regulatory requirements.
Core Responsibilities
- Document Development: Autonomously develop study-related documents and plans.
- Team Leadership: Lead the Data Management team as the Lead CDM, including the creation of the Data Management Plan, eCRF completion guidelines, and Data Edit Checks Document.
- Data Cleaning: Perform activities associated with data cleaning during clinical trial phases, including start-up, conduct, and closeout activities.
- Sponsor Relations: Build effective relationships with assigned sponsors, manage grievances, and drive strategic partnerships.
- Data Query Management: Proactively raise data queries in the Electronic Data Capture (EDC) system and collaborate with Clinical Research Associates (CRAs) and site staff for timely resolution.
- Communication: Maintain effective communication across the study team to manage ongoing study expectations and issues.
- Audit Participation: Engage in study-specific or vendor audits conducted by sponsors or regulatory agencies and respond to audit observations as required.
- Adverse Event Reporting: Ensure that Serious Adverse Events (SAEs) are reported as per protocol requirements.
Qualifications, Skills, and Experience
- Bachelor’s degree in life sciences, pharmacy, nursing, or an equivalent field, or significant industry experience.
- Minimum of 2 years of experience as a Clinical Data Manager in a CRO or pharmaceutical company.
- Formal ICH GCP training with knowledge of ICH GCP guidelines and regulatory requirements.
- Proficiency in maintaining client confidentiality.
- Strong written and verbal communication skills for effective stakeholder engagement.
- Problem-solving capabilities and sound judgment.
- Ability to thrive under pressure in a multidisciplinary team setting.
- A commitment to a positive and dynamic team culture.
What We Offer
- An agile and flexible workplace that values work-life balance.
- Opportunities for professional development and career progression.
- A sense of community and stability within the organization.
- Engagement with a leadership team focused on common goals.
- A stimulating work environment with project diversity and intellectual challenges.
How to Apply
If you are interested in becoming a part of the Avance Clinical team, please submit your CV and cover letter as a single Microsoft Word document.
