Job Description

Senior Clinical Data Manager - Medical Device Project Management: Represent Data Management in study team meetings, providing data status metrics and providing guidance on issues related to data management. Responsible for study Data Management activities from study start up to close out. Author Data Management timelines for assigned studies. Manage performance, quality, and timeliness of data from service providers (e.g., Central Reading Centers, Labs, Medical Coders). Data Management Documents: Author Data Management documentation (e.g. Data Management Plans, Data Review Guidelines and eCRF Completion Guidelines, and Study Timelines, etc.) Author Data Management training materials used for Investigator Meetings, in-house personnel, and site staff. Maintain Data Management project documentation including vendor files in an audit- ready manner. Assist the Lead Clinical Programmers with the creation and maintenance of Data Transfer Agreements. Data Review: Lead and perform regular data review across studies to identify quality issues, data trends/outliers and generate queries as necessary. Review and reconcile data from external sources. Database Build and User Acceptance Testing (UAT): Assist with the creation of the CRF and Edit Check Specifications documents. Perform User Acceptance Testing (UAT) of clinical databases including EDC. EDC User Management: Manage EDC User Access for all assigned studies. Collaboration with Cross-Functional Teams: Provide ongoing day-to-day support to the Clinical Study Teams to ensure all data is reviewed and discrepancies are resolved. Collaborate with internal team and stakeholders to ensure deliverables meet timelines. Work with Clinical Programming to produce additional reports outside of the Data Review Guidelines to facilitate efficient data review and cleaning. Facilitate cross-functional Data Management meetings and discussions with Study Managers, Clinical Study Teams, Project Managers, Programming and Regulatory. Generate reports or data listings for study teams as needed. Review Protocol and provide feedback to the Clinical Study Team on data collection related items. Process Improvement: Participate in the review and update of the Data Management standard operating procedures, work instructions, and templates. Participate in the development of departmental processes and procedures. Additional Skills & Qualifications Minimum of 5 years of experience working in clinical data management, preferably in the pharmaceutical or medical device industry. Understanding of clinical trial process. Understanding of FDA/ICH guidelines and industry/technology standard practices. Understanding of Good Clinical Data Management Practices (GCDMP) and other regulatory guidelines specific to data management. Hands-on working knowledge of Electronic Data Capture (EDC) systems (e.g. MedNet, Rave, Veeva Vault EDC, etc.). Hands-on ability to review data and ability to use various reporting and analytics tools. Multi-tasking, problem-solving and verbal and written communication skills essential. Project Management experience Experience writing Data Management documentation (e.g. Data Management Plans, Data Review Guidelines, and eCRF Completion Guidelines, and Study Timelines, etc.) Excellent verbal and written communication skills. Ability to work well with others. Knowledge of CDISC Standards (CDASH, SDTM). Ability to effectively manage a variety of data management tasks for multiple clinical studies and different stages of activity. Flexibility in responding to change or business needs. Proven ability to preemptively identify data and system issues and mitigate risks to data quality. Desirable Familiarity with Ophthalmology Therapeutic area. Experience with creation of Case Report Forms and Edit Check Specifications. Pay and Benefits The pay range for this position is $58.00 - $60.00 Medical, dental & vision- Critical Illness, Accident, and Hospital- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available- Life Insurance (Voluntary Life & AD&D for the employee and dependents)- Short and long-term disability- Health Spending Account (HSA)- Transportation benefits- Employee Assistance Program- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Aliso Viejo,CA. Application Deadline This position will be accepting applications until Dec 7, 2024. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.

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