3 Edc Databases Jobs

Medpace, a rapidly growing global Clinical Research Organization (CRO), is excited to announce that we are looking for experienced professionals to join us as we prepare to launch our newest office in Hyderabad, India. This is more than just a job. It's an opportunity to be part of something from the very beginning. You will play a direct role in shaping the culture, building the team, and influencing how we grow in India. Your work will make a meaningful impact across global projects right from day one. Be a Founding Member: You will help establish and lead operations at our newest location. Immediate Impact: Your experience will directly influence Medpace's growth in the region. Career Growth: As the office grows, leadership and advancement opportunities will also increase. Global Reach: Work on cutting-edge clinical trials with international teams and top-tier sponsors. Strong Culture: Join a company known for its stability and commitment to professional development. Support & Infrastructure: While the Hyderabad office is new, you will be backed by the global resources and processes of a well-established CRO. If you are looking for a new challenge and want to be part of building something meaningful while advancing your career with a company that's investing in your region, we would love to hear from you. Responsibilities - Develop and review Data Management procedures for clinical trials with sponsor companies and other departments. - Establish/negotiate Data Management project timelines and ensure Data Management milestones are met. - Coordinate data transfers with the clinical database programmers, Project Manager, and external recipients. - Coordinate system development and ongoing maintenance in collaboration with the MCL programmers and MCL operational team. - Serve as the primary contact for MCL team members, sponsors, and external data management groups. Qualifications - Bachelor's degree with at least 7 years of Data Management experience in clinical research, prior experience in Core Lab preferred. - Experience in setting up and managing multiple clinical projects and acting as the main point of contact for the sponsor. - Computer experience with EDC databases and analysis software. - Possess an understanding of database structure and processes in data management. - Basic knowledge of medical terminology is needed, as well as knowledge of clinical research methodologies. Medpace Overview Medpace is a full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach. With headquarters in Cincinnati, Ohio, we employ more than 5,000 people across 40+ countries. Why Medpace People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. Medpace Perks - Flexible work environment - Competitive compensation and benefits package - Competitive PTO packages - Structured career paths with opportunities for professional growth - Company-sponsored employee appreciation events - Employee health and wellness initiatives Awards - Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024 - Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What To Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.,

Job purpose : The Clinical Database Programmer is a key member of Clinical Biometrics team. This individual will be responsible for providing database services including database design, creation, and validation to collect data for research, development, and/or marketed product. The individual should be able to ensure accurate data collection from electronic systems through error-free programming. This individual will work closely with the Biostatistics and Data Management team as well as other Ocugen team members to execute the statistical and data needs of the clinical studies. Duties and responsibilities : Collaborates with other team members to define database requirements . Involves in programming, validation of standard and study-specific electronic Case Report Forms (eCRFs). Troubleshoots and resolves database issues timely. Designs, implements and maintaining databases or collaborates on implementation and collection of data supporting research protocols. Provides database consultation for research programs. Collaborates on development of database specifications, data management plans, data transfer specifications, data review specifications and/or data quality review plan specifications Develops edit checks, QC, and validation reports to ensure quality data. Provides input to project timelines and ensures that project timelines for database deliverables are met. Ensures that project tasks are completed with acceptable quality. Ensuring data integrity ,security and availability. Perform database back ups and recovery. Attends team meetings. Additional tasks and projects as requested. Qualifications: BS/BA degree in Computer Science, or work-related experience. 5-8 years related experience. Experience with relational databases and Programming. Experience with developing eDC databases (e.g. Veeva Vault or RAVE), IRT systems (including randomization), and ePRO applications for data collection. Database programming language experience (e.g. SQL, PHP). Website programming language experience is a plus (e.g. HTML, Javascript) Statistical programming language experience is a plus (e.g. SAS, R, Python). Working knowledge of GCPs, ICH, FDA, and CDISC regulatory requirements governing clinical studies. Demonstrated attention to detail and outstanding organization skills. Self-motivated with a commitment to high quality, on-time deliverables. Working conditions: This position operates in an office and/or remote setting. Job may additionally require incumbent to be available outside of regular 9-5 hours to handle priority business needs. Physical requirements: This is a largely sedentary role.

Job purpose: The Clinical Data Manager is a key member of Ocugens clinical data management team. This individual will be responsible for ensuring quality data collection and management processes, CRF development, database design, data monitoring, and validation of entered data for clinical development, and/or marketed products. This individual will work closely with the Biometrics team and the rest of the team at Ocugen to execute the data collection needs of the research studies. Duties and responsibilities: Establishes data flow from collection to final analysis through a data management plan. Ensures the accurate collection of electronic data. Collaborates on implementation and collection of data supporting for research protocols. Develops data transfer specifications and data review specifications and/or data quality review plan specifications. Develops program standard and study-specific electronic Case Report Forms (eCRFs). Develop and revise SOPs, implement DMP and strategies. Develop and implement risk management strategies. Prepare and participate in Audits. Develops edit checks, validation reports to ensure quality data. Provides input to project timelines and ensures that project timelines for database deliverables are met. Ensures that project tasks are completed with acceptable quality. Ensure all required documentation is completed in a timely manner. Lead junior Data management staff. Collaborates with other functional teams to ensure proper output of clinical data as needed for deliverables. Additional tasks and projects as requested. Qualifications : BS degree in clinical, biological or mathematical sciences, or related field or nursing qualification, or work- related equivalent. 6+ years direct clinical data management experience in pharmaceutical development or CRO environment. Experience with clinical trials. Experience with CRFs, and in the development process of EDC databases, IRT systems and diary applications for data collection. Strong knowledge of GCPs, ICH, FDA, and CDISC regulatory requirements governing clinical studies. Demonstrated attention to detail and outstanding organization skills. Self-motivated with a commitment to high quality, on-time deliverables. Excellent communication and collaboration skills with a team-oriented approach. Demonstrated ability to identify and resolve issues and effectively manage timelines. Experience in working with USA biopharmaceuticals/pharmaceuticals companies or client. Strong communications skills and a track record of accomplishment managing client relationships as well as regulatory agencies for USFDA and EMA. Working conditions : This position operates in an office setting, in person. Remote work will be limited. Job may additionally require incumbent to be available outside of these hours to handle priority business needs. Physical requirements: This is a largely sedentary role.