Job Opportunities API

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).