As the Manager, Clinical Data Management (CDM) at KlinEra Global Services, a leading Contract Research Organization (CRO), you will be responsible for overseeing the planning, execution, and management of clinical data management activities across multiple clinical trials. Your role involves ensuring the integrity of clinical trial data by managing data collection, data validation, and data quality. Additionally, you will lead a team of data managers and collaborate with cross-functional teams to ensure compliance with protocols, regulatory standards, and company policies. Key Responsibilities: Data Management Oversight: Lead and manage data management activities for clinical trials, ensuring timelines, budgets, and quality standards are met. Team Leadership: Supervise, mentor, and provide guidance to a team of Clinical Data Managers (CDMs) and other data management staff. Ensure professional development and training opportunities for the team. Study Planning: Collaborate with project teams to design and implement data management plans (DMPs), data collection tools (e.g., CRFs), and systems. Oversee the creation of data management documents such as data dictionaries and edit checks. Quality Assurance: Ensure the highest data quality by implementing quality control processes. Lead data review activities, such as query generation, resolution, and risk-based data validation. Vendor Management: Manage relationships with external data management vendors and provide oversight to ensure service delivery meets expectations. Regulatory Compliance: Ensure all data management activities comply with regulatory requirements (e.g., GCP, FDA, EMA) and the company's standard operating procedures (SOPs). Cross-Functional Collaboration: Work closely with clinical operations, biostatistics, medical writing, and regulatory teams to facilitate smooth data transfer, analysis, and reporting. Reporting and Documentation: Prepare and present reports on data management progress and metrics to stakeholders. Maintain accurate documentation throughout the trial lifecycle. Risk Management: Identify potential risks to data integrity and timelines and work with project teams to implement mitigation strategies. Technology and Tools: Ensure efficient use of clinical data management systems (e.g., EDC systems, CTMS) and other relevant tools for data collection and analysis. Continuous Improvement: Drive continuous improvement initiatives in clinical data management processes to enhance efficiency, quality, and regulatory compliance. Qualifications: Education: Bachelor's degree in Life Sciences, Medical or Clinical Research, or a related field. Advanced degree (e.g., Master's) is a plus. Experience: Minimum of 5-7 years of experience in clinical data management, with at least 2-3 years in a managerial role within a CRO or pharmaceutical company. Proven experience in leading and managing a team of clinical data professionals. In-depth knowledge of GCP, ICH guidelines, and regulatory requirements related to clinical data management. Strong experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS). Experience with clinical trial software and programming languages (e.g., SAS, SQL) is advantageous. Skills: Excellent organizational and time management skills with a proven ability to manage multiple projects simultaneously. Strong problem-solving, analytical, and decision-making abilities. Ability to collaborate and communicate effectively with internal and external stakeholders. Strong leadership, mentoring, and interpersonal skills. Detail-oriented with a commitment to data quality and compliance. Preferred Qualifications: Certifications: Certification in Clinical Data Management (CDMP) or related certifications (e.g., GCDMP) preferred. Experience with Global Trials: Experience managing global clinical trials across multiple regions and countries. Software Proficiency: Familiarity with clinical data management tools such as Medidata Rave, Oracle InForm, Veeva Vault, and other industry-standard platforms.,
As the Manager, Clinical Data Management (CDM) at KlinEra Global Services, a leading Contract Research Organization (CRO), you will oversee the planning, execution, and management of clinical data management activities across multiple clinical trials. This includes the oversight of data collection, data validation, data quality, and the overall integrity of clinical trial data. You will manage a team of data managers and work closely with cross-functional teams such as clinical operations, biostatistics, and regulatory affairs to ensure that clinical trials are executed in compliance with protocols, regulatory standards, and company policies. Key Responsibilities: - Lead and manage data management activities for clinical trials, ensuring timelines, budgets, and quality standards are met. - Supervise, mentor, and provide guidance to a team of Clinical Data Managers (CDMs) and other data management staff. Ensure professional development and training opportunities for the team. - Collaborate with project teams to design and implement data management plans (DMPs), data collection tools (e.g., CRFs), and systems. Oversee the creation of data management documents such as data dictionaries and edit checks. - Ensure the highest data quality by implementing quality control processes. Lead data review activities, such as query generation, resolution, and risk-based data validation. - Manage relationships with external data management vendors and provide oversight to ensure service delivery meets expectations. - Ensure all data management activities comply with regulatory requirements (e.g., GCP, FDA, EMA) and the company's standard operating procedures (SOPs). - Work closely with clinical operations, biostatistics, medical writing, and regulatory teams to facilitate smooth data transfer, analysis, and reporting. - Prepare and present reports on data management progress and metrics to stakeholders. Maintain accurate documentation throughout the trial lifecycle. - Identify potential risks to data integrity and timelines and work with project teams to implement mitigation strategies. - Ensure efficient use of clinical data management systems (e.g., EDC systems, CTMS) and other relevant tools for data collection and analysis. - Drive continuous improvement initiatives in clinical data management processes to enhance efficiency, quality, and regulatory compliance. Qualifications: Education: Bachelors degree in Life Sciences, Medical or Clinical Research, or a related field. Advanced degree (e.g., Masters) is a plus. Experience: - Minimum of 5-7 years of experience in clinical data management, with at least 2-3 years in a managerial role within a CRO or pharmaceutical company. - Proven experience in leading and managing a team of clinical data professionals. - In-depth knowledge of GCP, ICH guidelines, and regulatory requirements related to clinical data management. - Strong experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS). - Experience with clinical trial software and programming languages (e.g., SAS, SQL) is advantageous. Skills: - Excellent organizational and time management skills with a proven ability to manage multiple projects simultaneously. - Strong problem-solving, analytical, and decision-making abilities. - Ability to collaborate and communicate effectively with internal and external stakeholders. - Strong leadership, mentoring, and interpersonal skills. - Detail-oriented with a commitment to data quality and compliance. Preferred Qualifications: - Certification in Clinical Data Management (CDMP) or related certifications (e.g., GCDMP) preferred. - Experience managing global clinical trials across multiple regions and countries. - Familiarity with clinical data management tools such as Medidata Rave, Oracle InForm, Veeva Vault, and other industry-standard platforms.,
Company Description Since 2005, KlinEra has partnered with major pharmaceutical, biotech, and device companies, providing innovative and customized clinical trial and research services. The company has successfully completed over 50 large-scale Phase 1, 2, and 3 trials, focusing on clinical trials in India while implementing high-quality protocols and Good Clinical Practices (GCP). KlinEra serves clients in various therapeutic areas including cardiology, infectious diseases, oncology, and more. The organization is diverse with offices located in Mumbai, India, and San Jose, CA, USA. About the role: As a Senior CPM, you will oversee complex program of Global studies, act as a trusted advisor to sponsors, and mentor CPMs and cross-functional team members. You will own delivery excellence, risk management, and commercial stewardship for assigned projects. Please email your CV along with a Cover Letter to Abdul.ansari@klinera.com Key responsibilities Lead end-to-end delivery for complex/late-phase or multi-country trials; oversee multiple concurrent Global studies or an integrated program. Serve as senior client liaison, providing strategic delivery guidance, issue resolution, and governance reporting. Shape protocol operationalization, country and site strategy, and enrollment rescue plans; lead risk assessment and Quality by Design activities. Own project financials: accurate forecasting, margin protection, change order strategy, and variance root-cause analysis. Oversee vendor strategy and performance (central labs, Medical imaging, etc.); negotiate scopes with Procurement/BD as needed. Ensure inspection readiness at all times; lead audit responses and CAPA programs; partner closely with QA. Guide cross-functional leaders (Clinical, DM, Stats, Safety, Medical Writing, Regulatory) to align on critical path and scenario plans. Coach/mentor CPMs, CTLs/CRAs; may provide line management for a small team depending on portfolio needs. Contribute to proposals, bid defences, and operational strategy in partnership with BD and Solutions teams. Required qualifications and experience Bachelor’s degree in Life Sciences, Pharmacy, or related field; PhD, advanced degree or certifications (PMP/PRINCE2, ACRP) are a plus. Minimum of 8-10 years of experience as a Project Manager delivering Phase I–IV trials in a CRO or sponsor setting. Proven track record of leading multi-center, regional or global trials with measurable success on timelines, quality, and budget. Advanced skills in trial management, clinical operations, protocol implementation, and stakeholder leadership. Line management experience and capability building/mentoring across teams. Strong commercial acumen: budget management, change orders, contract/SOW interpretation. Excellent communication, negotiation, and conflict resolution skills; adept at working in fast-paced, dynamic environments. Experience across multiple therapeutic areas (e.g., Oncology, Hepatology, metabolic, CNS). Experience with India and global regulatory/ethics landscapes (CDSCO/NDCTR, ICH-GCP, FDA/EMA/MHRA). Depth with operational analytics, enrollment modeling, and risk signal detection tools.