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).