Lead Clinical Data Manager
Katalyst Healthcares and Life Sciences
Responsibilities:
- Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards.
- Provide strategic oversight and direction to CRO clinical data management teams for assigned studies.
- Develop and implement data management plans, case report forms (CRFs), edit checks, and data validation plans in alignment with study protocols and regulatory requirements.
- Oversee the design, build, and validation of clinical databases using Medidata Rave EDC, ensuring optimal configuration and functionality.
- Conduct thorough reviews of clinical data, identifying trends, inconsistencies, and potential issues that may impact data quality or study outcomes.
- Collaborate with cross-functional teams including Biostatistics, Clinical Operations, Safety, and Regulatory to ensure alignment of data management strategies with overall clinical development goals.
- Provide oversight, and performance management of external data management vendors.
- Maintain SOPs, guidelines, and best practices for clinical data management processes.
- Represent the Clinical Data Management function in internal and external meetings, providing expert guidance on data-related matters.
- Stay current with industry trends, regulatory requirements, and technological advancements in clinical data management, particularly in the oncology field.
- Bachelor's degree in Life Sciences, Computer Science, or a related field; advanced degree preferred.
- minimum of 7+ years of clinical data management experience in the biotechnology or pharmaceutical industry.
- Experience managing oncology clinical trials data, including a deep understanding of oncology-specific data requirements and challenges.
- Expert-level proficiency with Medidata Rave EDC, including system configuration, form design, and edit check programming.
- Strong knowledge of clinical research processes, FDA & ICH guidelines, GCP, GCDMP, and CDISC standards.
- Demonstrated experience in CRO and vendor oversight.
- Excellent project management skills with the ability to manage multiple studies simultaneously.
- Strong analytical and problem-solving skills with meticulous attention to detail.
- Outstanding communication and interpersonal skills, with the ability to effectively collaborate with diverse stakeholders.
- Proficiency in Microsoft Office Suite and familiarity with statistical software (e.g., SAS, R) is a plus.
- CCDM® (Certified Clinical Data Manager) certification.
- Experience with risk-based monitoring in oncology studies.
- Knowledge of emerging technologies in clinical data collection and management (e.g., ePRO, wearables, AI/ML applications).
Vacancy posted 8 days ago
Similar jobs that could be interesting for youBased on the Lead Clinical Data Manager in Irvine, CA vacancy
- ...Clinical Data Management Lead Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. Provide strategic oversight and direction to CRO clinical data management teams...SuggestedWork at office
Katalyst HealthCares & Life Sciences
Irvine, CA5 days ago - ...planning, direction and implementation of clinical systems for data collection which may include vendor... ...Data Validation Specifications, Data Management Plans, eCRF Completion Guidelines, and... ...to archival with at least 5 years in lead role for clinical development programs...Suggested
Katalyst Healthcares and Life Sciences
Irvine, CA4 days ago $38.94 - $48.65 per hour
...professionals with meaningful career opportunities. We are seeking a Clinical Data Manager II to support our client, a medical device company.... ...for clinical studies - from startup to closeout. You'll lead data cleaning strategies, drive cross-functional collaboration...SuggestedHourly payTemporary workLocal areaMonday to FridayEastridge Workforce Solutions
Aliso Viejo, CA1 day ago- ...Job Description Trident Consulting is currently seeking a Clinical Data Manager for one of our industry leading clients. Role: Clinical Data Manager II Location: Aliso Viejo, CA - Onsite Duration: 6 Months Shift: 1st Shift Employment Type: Temporary /...SuggestedTemporary workShift workDay shift
Trident Consulting
Aliso Viejo, CA5 days ago - ...Trident Consulting is seeking a "Clinical Data Manager II " for one of our clients in " Aliso Viejo, CA (Onsite) " A global leader in business and technology services. Role: Clinical Data Manager II Location: Aliso Viejo, CA (Onsite) Type:...SuggestedContract work
Trident Consulting
Aliso Viejo, CA2 days ago $26 - $29 per hour
Trident Consulting Inc is seeking an experienced Clinical Data Manager II located in Aliso Viejo, CA. This temporary/contract position involves supporting clinical study data management from startup to closeout. The ideal candidate will possess 2-5 years of relevant experience...Temporary work- Global Talent Partners Veterinary in Costa Mesa seeks a Specialty Medical Director to lead clinical and administrative practices in a top-tier animal hospital. You will oversee various specialties while supporting a multidisciplinary approach in a 24/7 operational environment...
$99k - $232k
...Specialty/Competency: Data, Analytics & AI Industry/Sector: Not Applicable Time... ...leveraging team member’s unique strengths, and managing performance to deliver on client... ...success of our Firm. You are expected to lead with integrity and authenticity, articulating...Full timeH1bPwC
Irvine, CA5 days ago- BiVACOR Inc. in Huntington Beach is seeking a Clinical Research Manager to lead the US IDE study operations of a groundbreaking total artificial heart project. You will manage clinical research teams and ensure compliance with FDA regulations while developing key clinical...
$110k - $150k
BiVACOR is seeking a Senior Clinical Research Manager for its Huntington Beach location. In this pivotal role, you will manage all US IDE clinical study operations and lead a team of clinical professionals ensuring compliance and driving clinical strategy for the world...- A healthcare company is seeking a Clinical Manager to oversee RN services in the community and clinic. Candidates should be licensed nurses with 3-5 years of experience. The role includes leading a team to provide exceptional patient care. Benefits encompass health coverage...
- ...HDR is seeking a Power Generation Data Center Lead to drive expertise in power generation projects supporting data centers. This leadership role involves significant client interaction, collaboration across teams, and ensuring the quality and timely completion of projects...
HDR
Irvine, CA5 days ago $169.58k - $232.05k
...HDR is seeking a Power Generation Data Center Lead to be part of our Power Generation Practice. The person will work with our national Power... ...power generation technologies. Client development and management skills with a strong ability to maintain a high standard of...Full timeTemporary workPart timeWork at officeHDR
Irvine, CA5 days ago$194.3k - $259.1k
Overview As our Big Data Manager, you will manage two to three teams of data scientists attached to business units within our organization. You will manage change both internally on your own teams and externally with the business units you serve. You’re focused on bringing...Full timeLocal area$27.87 - $34.41 per hour
PATH (People Assisting The Homeless) in Costa Mesa, CA is hiring a Data Management Specialist to support the CES Administration Team in their mission to assist individuals and families facing homelessness. This role involves data management tasks, compliance monitoring,...Hourly pay$90k - $120k
Sanmina Corporation is seeking a Supply Chain Specialist Manager to oversee the flow of goods at their Viking Technology division in Costa Mesa, CA. This role involves optimizing supply chain processes, managing vendor relationships, and ensuring compliance with industry...$124k - $280k
...Specialty/Competency: Data, Analytics & AI Industry/Sector: Not Applicable Time... ...skills, knowledge, and experiences you need to lead and deliver value at this level include... ...current and future business needs. As a Senior Manager you lead large projects, innovate...Full timeH1bPwC
Irvine, CA4 days ago$129k - $171k
Anduril Industries is looking for a Supply Chain Master Data Engineer in Costa Mesa, CA, to maintain and ensure the integrity of critical supply chain data. This role involves governance of supplier records and part information, and collaboration with multiple departments...$170k - $252.5k
...Who We Are Looking ForWe are seeking an experienced Data Integration Lead to lead an engagement, and corresponding execution, with one of State... ...alignedStrong executive communication and stakeholder management skills, with the ability to lead discussions with sophisticated...Temporary workInterim roleWork at officeFlexible hoursState Street Corporation
Irvine, CA5 days ago$109.5k - $208.5k
...and YouTube. Job Description Purpose: The Clinical Data Strategy and Operations (CDSO) Data Strategy Lead serves as the study start-up domain expert and key... ...for the study team. Through strong project management, risk oversight, and continuous process optimization...Full timeWork experience placementLocal area3 days per week- Anduril-1 is seeking a Data Product Manager to drive the adoption of an enterprise semantic layer. This role integrates product management and technical enablement to facilitate data-driven innovations within the defense sector. The ideal candidate will collaborate with...
- Join to apply for the Data Scientist Lead (Remote) role at Jobright.ai 4 days ago Be among the first... ...Mesa, CA . Senior Data Analyst - Managed Care Operations - CA Long Beach, CA $6... ...& BigQuery Principal Data Scientist, Clinical (U.S. Remote & Temp to Hire) SAP iXp Intern...Remote jobFull timeTemporary workInternship
$125.5k - $230.2k
...sector. You will have the opportunity to lead and develop your skill set to keep up with the ever‑growing demands of the modern data platform. During implementation you will solve... ...your skillset and build your career. As a Manager in Data Architecture, you will have the...Summer holidayFlexible hoursEY
Irvine, CA4 days ago$125.5k - $230.2k
.... Join EY and help to build a better working world. AI & Data - Data Architecture – Manager – Power & Utilities Sector EY is seeking a motivated professional... ...& Utilities sector. You will have the opportunity to lead and develop your skill set to keep up with the ever-...Summer holidayFlexible hoursErnst & Young Oman
Irvine, CA1 day ago- Camino Health Center is looking for a Clinic Manager in Lake Forest, CA, who will supervise the efficient flow of medical, behavioral health, and dental services. The role includes coordinating daily activities, enhancing patient experience, and managing support staff....
$64k - $84k
...America, Inc. GLOVIS America, Inc. is a leading third-party logistics provider... ...Summary The Supervisor - Performance Management serves as a key contributor to operational... ...business intelligence solutions, and providing data-driven insights that support strategic...Temporary workSummer workWork at officeLocal areaFlexible hoursGrandir UK
Irvine, CA5 days ago$166k - $220k
Front Door Defense is seeking a Senior Data Engineer in Costa Mesa, California, responsible for designing and implementing scalable data... ...across teams to build a robust data platform while leading future data initiatives. The ideal candidate will have extensive...- ...area) Department: Enterprise Tech & Services Enterprise Data Centers Reporting Manager: Vice President, EDC Engineering & Operations Position... ...Key Responsibilities: Serve as primary project lead for all assigned mechanical, electrical, and critical infrastructure...Contract workRemote work
Denken Solutions
Irvine, CA2 days ago $150k - $200k
...DIRECTOR, DATA SCIENCE REPORTS TO: CHIEF DIGITAL OFFICER STATUS: EXEMPT Summary... ...intelligent systems. The Director will lead a high-performing team and ensure the... ...attitude and teamwork with customers, peers and management. Adhere to all local, federal and...Work at officeLocal areaFlexible hoursShift workBoot Barn
Irvine, CA3 days ago$30 - $36 per hour
...B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products... ...Braun Medical, visit Position Summary The QC Microbiology Lead provides technical leadership for lab operations, ensuring timely...Hourly payWork at officeRelocationMonday to FridayShift workB. Braun US Pharmaceutical Manufacturing LLC Careers
Irvine, CA12 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Lead Clinical Data Manager. Be the first to apply!
Related searches
- healthcare consulting manager Irvine, CA
- senior director clinical development Irvine, CA
- medical device manager Irvine, CA
- healthcare supervisor Irvine, CA
- medicare medical director Irvine, CA
- health economics manager Irvine, CA
- senior clinical data manager Irvine, CA
- director of health information management Irvine, CA
- occupational health manager Irvine, CA
- health insurance manager Irvine, CA