Senior Clinical Data Specialist (India)

Exciting Opportunity at Bioforum India!

Minimum Requirements:

• Bachelor’s degree (or equivalent education) in health, clinical, biological, or mathematical sciences, or a related field.

Experience:

• Preferred 6 + years of experience in the clinical research industry with 4 years proven expertise in data management.

Skills & Competencies:

• Proficient in English.


• Strong communication and Collaboration Aptitude.


• Strong administrative skills (Planning, organizing, time management etc.).


• Excellent skills in Data Management.


• Proven leadership and team management skills to successfully lead initiatives and work independently.
  


• Proven skills in establishing and maintaining effective working relationships with co-workers, managers, and Sponsors/External Vendors.


• Good problem-solving skills.


• Self-Sufficient Work Ethic.


• Strong attention to detail.


• Proficient in Microsoft Office products.


• Proven Technical abilities.


• Knowledge of the clinical trial process flow.


• Excellent understanding of Good Clinical Practices (GCP) and introductory knowledge of relevant regulatory guidelines.


• In-depth understanding of data management principles, processes, and methodologies.


• Solid gasp with medical terminology and basic concepts in pharmacology, anatomy, and physiology

Responsibilities:

Team Leadership

• Demonstrate strong work ethic, commitment, and a commitment to quality, serving as a role model for team members to emulate.


• Foster a cohesive and motivated data management team by promoting a positive work environment, open communication, and teamwork.


• Supervise and lead Clinical Data Specialists, providing guidance and support and mentoring on data management aspects.


• Support the Clinical Data Strategy Lead in driving timelines and deliveries, leading other data Clinical Data Specialists in the process.


• Coordinate data reviews by assigning tasks and responsibilities to team members, ensuring efficient workload distribution.


• Oversight on DM activities meet the requirements set by scope of work and budget.


• Stand in as back-up to the Clinical Data Strategy Lead and other Clinical Data Specialists.

 Operational Execution

• Ensure adherence to established Business Practices, Standard Operating Procedures, and Working Instructions while also performing additional tasks assigned by management.


• Review study specific protocols and provide input in the design of eCRF utilizing company and/or sponsor data standards, collaborating with Clinical Data Strategy Leads and Head of Data Operations as applicable.


• Assist in defining tailored data checks, both automated and manual, for specific studies.


• Lead and direct the development and implementation of Data Cleaning Listings to ensure that the organizational final data assets are fit for purpose.


• Actively contribute to the development of the study specific Data Management documentations (Data Management Plan, Data Review Plan and Specifications) and comply with all relevant sections.


• Lead and Perform data validation efforts prior to go live and as applicable during the study lifecycle.


• Independently oversee data reviews for studies, encompassing clinical databases and external data, in alignment with organizational standards and the study's scope of work.


• Serve as escalation point for unresolved data issues – driving appropriate resolutions with external and internal team members.


• Pro-actively identify and manage risks on assigned projects to ensure timelines and customer expectations are met.


• Support with holistic data reviews and provide insights on Data Trends, Risks and Anomalies through the use of in-house tools and software.

Documentation and Reporting

• Maintain accurate and up-to-date project documentation, including project plans, meeting minutes, and correspondence.


• Generate project-related reports and metrics to monitor project performance and ensure transparency.


• Ensure timely and appropriate filing of all Data Management project documentation.

 Quality Control & Assurance

• Ensure clinical trial data completeness, integrity, and consistency. 


• Ensure data management activities comply with industry standards, regulatory requirements, study-specific protocols, and organizational operating procedures.


• Implement and execute robust quality control procedures to identify and resolve data-related issues.


• Support Quality Assurance (QA) and Bioforum management to address project related Corrective and Preventive Actions (CAPAs) as required.

 Cross-Functional Collaboration

• Develop and maintain effective communication and working relationships with CDM team.


• Collaborate with Clinical Data Strategy Leads and other CDM stakeholders throughout the lifecycle of the study to ensure timelines are met for all study deliverables. 


• Work collaboratively to address data-related issues and discrepancies promptly.


• Collaborate with internal and external customers as Subject Matter Expert on Data Management aspects.

 Efficiencies and Innovation

• Identify opportunities to streamline data management processes, enhance efficiency, and reduce data-related errors.


• Support on CDM Initiatives and Process improvements.

 Training and Mentorship

• Develop and provide training programs for the data management team to enhance their skills and knowledge.


• Serve as Subject Matter Expert (SME).