3 Clinical Protocol Jobs

Position Overview We are seeking an experienced Clinical Data Specialist II to join our clinical research team in Chennai. The successful candidate will be responsible for accurate and timely data entry into Electronic Data Capture (EDC) systems from various e-source documents, including real-time data and Clinical Research Information Officer (CRIO) sources. Key Responsibilities Data Management Perform accurate data entry into EDC systems from e-source documents (Real-time & CRIO). Conduct data verification and validation to ensure data integrity. Execute data reconciliation activities between different data sources & EDC. Maintain detailed logs of data entry activities and progress tracking. Clinical Protocol & Documentation Review and interpret clinical study protocols to understand data collection requirements. Ensure compliance with protocol specifications during data entry. Maintain thorough understanding of case report forms (CRFs) and CRF completion guidelines (eCCG). Support protocol amendments and updates as required. Query Management Respond to data queries in a timely and accurate manner. Raise queries for missing, inconsistent, or unclear data points in CTMS/emails. Collaborate with clinical sites and monitors to resolve data discrepancies. Close queries CTMS upon satisfactory resolution & respond back to queries in EDC within sponsor required timelines. Quality Assurance Conduct thorough quality checks on entered data with zero-defect expectations. Participate in data review meetings, SIVs, PSVs & Study Kick-off meetings. Ensure adherence to Good Clinical Practice (GCP) guidelines. Support regulatory inspections and audits. Maintain 100% data accuracy standards across all deliverables while meeting strict project timelines without compromising data quality. Third-Party Data Review Review and validate data received from third-party vendors (Lab, PK, PD, PRO & eCOA) Cross-reference third-party data with study databases. Identify and resolve discrepancies in external data sources. Coordinate with immediate supervisor for data clarification and correction. Required Qualifications Experience 4-5 years of experience in CRC/CRA/Clinical Data Specialist or related field. Proven experience with CTMS systems (preferably Real time, CRIO, Veeva Vault or similar platforms). Proven experience with EDC systems (preferably Zelta, Medrio, Medidata Rave, Oracle InForm, or similar platforms). Experience in pharmaceutical, SMO, or CRO environment. Technical Skills Proficiency in Microsoft Word & Excel (Ex: Pivot tables, VLOOKUP, data analysis functions). Knowledge of regulatory guidelines (ICH-GCP, FDA, EMA). Core Competencies Analytical Thinking: Ability to identify patterns, discrepancies, and data inconsistencies. Clinical Protocol Reading: Strong comprehension of complex clinical protocols and procedures. Data Entry & Reconciliation: High accuracy in data transcription and validation. Attention to Detail: Meticulous approach to data review and quality control. Problem-Solving: Effective resolution of data-related issues and queries. Quality Excellence: 100% accuracy expected in all data entry activities with zero tolerance for errors. Time Management: Ability to deliver timely data entry while maintaining quality standards. Pressure Management: Proven ability to work effectively in high-pressure, deadline-driven environments. Cross-Functional Experience: Demonstrated ability to work with cross-functional teams including clinical operations, biostatistics, regulatory affairs, and medical affairs. Communication Skills Excellent verbal communication skills with strong documentation and reporting capabilities. Ability to interact professionally with clinical sites, sponsors, and team members. Team player with collaborative mindset and ability to support colleagues. Educational Background Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related field. Experience as CRC/CRA in SMO/CRO organizations (Preferred). EDC & CTMS certifications (Preferred).

As a Clinical Database Programmer at ProcDNA, you will play a crucial role in designing the eCRF layout and corresponding database, implementing dynamic rules based on Sponsor requirements, and creating trial-specific Edit Checks. Your responsibilities will also include developing Custom Functions using C# for Rave studies or other EDC systems, incorporating internal and Sponsor feedback, and maintaining eCRFs and components as per protocol amendments or metadata updates. Additionally, you will support CRO trial activities, create reports using JReview, SAS, BOXI, and handle migration processes for Post Go-Live studies. To excel in this role, you must have a deep understanding of Clinical Protocol, medical and scientific principles of conducting clinical trials, and expertise in Critical Data Point Strategy (CDPS) or SDV implementation. Your strong writing, communication, research, and analytical skills will be essential in gathering, interpreting, and synthesizing data accurately. Attention to detail, project management capabilities, and the ability to manage a team are also crucial for success in this position. Ideally, you should be Certified in Medidata Study Builder (SDBE), Oracle - InForm/Central Designer, or Veeva Studio, with a background in Computer Science-based courses or Circuit Branches (B.E./B.Tech, M.Sc./MCA, B.Sc./BCA). Joining ProcDNA will offer you the opportunity to work in a fast-growing consulting firm that is making a real impact in the healthcare sector, collaborate directly with leadership, and contribute to shaping marketing strategies. Currently, we are seeking candidates for this role in Pune, Gurgaon, Bangalore, Kochi, Hyderabad, and Chennai. If you are passionate about database management, dynamic rules implementation, project management, and have a keen eye for detail, this role at ProcDNA could be the perfect fit for you. Apply now and be part of a team that values innovation, collaboration, and excellence in Commercial Analytics and Technology solutions.,

Job Overview In the role of Pharmaceutical Medical Writer, you will have the opportunity to work closely with other writers, project managers and support specialists to produce a wide variety of regulatory and scientific reports, plans, and other written deliverables for pharma/biotech clients. Roles and Responsibilities As a member of our project writing team, you will be responsible for producing assigned written documents and reports to a high standard. Your specific responsibilities include: Primary responsibility for developing and delivering accurate, high-quality scientific content within the project specifications, timeline, and budget Interacting regularly with clients, project managers, and other medical writers to ensure scientific accuracy, quality, and successful completion of projects Interpreting and analyzing complex datasets Editing content written by others; improve the clarity in others' writing and serve as a mentor to junior members of the medical writing team Lead client and internal meetings as necessary Organize own project workload and tasks, identify project needs and adhere to project timelines. Understand client expectations and work to meet those expectations through teamwork, adherence to deadlines, problem-solving and scientific knowledge. Effectively collaborate with other members of the project writing team. Working with a Criterion Edge Project Manager to document your assigned tasks, time estimates and due dates into project plana, and provide weekly progress updates. Proactively identify potential project risks and bring those forward to the overall project team to discuss and identify solutions Ensure and coordinate quality control (QC) checks for accuracy following established internal QC processes. Provide written and verbal feedback to junior staff and clients when appropriate. Qualifications and Skills 4 or more years of pharmaceutical industry experience, including 3 years of clinical and regulatory writing Submit for review, and obtain approval for clinical and nonclinical regulatory documents including, but not limited to, Clinical Protocols, Clinical Study Reports (CSRs), Investigator's Brochures, and Briefing Books Minimum of a BSc in a life sciences or related discipline / related field. Independently or with minimal supervision write, edit, and perform data verification Collaborate effectively with other functional area authors to achieve submission schedules Advanced word processing skills, including Microsoft Office (including Word), Adobe Acrobat, Excel and collaborative document sharing platforms such as SharePoint; ability to learn and adapt to various IT systems. High level of English fluency or native English speaker, with excellent oral (including presentation) and written communication, including grammatical/technical writing skills. Able to interact confidently with external stakeholders Capable of working independently to achieve assigned project goals with minimal supervision. Excellent attention to detail and accuracy. Contribute, collaborate, share responsibilities, and support other team members to ensure success with tasks/projects. Location: Remote- Bengaluru,Hyderabad,Delhi / NCR,Chennai,Pune,Kolkata,Ahmedabad,Mumbai