Lead (Clinical) Data Manager
4 weeks ago
POSITION SUMMARY:
The Lead (Clinical) Data Manager (LDM) is responsible for accuracy, reliability, and completeness of Phase I-IV clinical databases and will lead the end-to-end data management activities for assigned trials.
ESSENTIAL FUNCTIONS:
The responsibilities of this role include, but are not limited to, the following:
Responsible for quality and timely delivery of clinical trials data. Participate in vendor evaluation, qualification, and selection activities, including, but not limited to, review and assessment of SOP / Work Instructions, contracts, and budgets. Serve as Data Management representative at trial-specific meetings and as primary contact for external vendors; develop, track, analyze, and provide regular status reports on vendor activities as well as internal data management performance metrics. Provide oversight of designated activities outsourced to CROs, external consultants, central and specialist labs, and other data vendors utilizing key performance indicators, metrics, and timelines to assess vendor quality and performance. Escalate issues as needed. Participate in protocol design and review, providing key input related to the operationalization of the design and data collection, while ensuring consistency and adherence to data standards. Lead or assist with development of trial-specific Data Management documents, including, but not limited to, Data Management Plan, eCRF Completion Guidelines, database (eCRF/edit check) specifications, data validation/data quality plan, external data transfer specifications, and SDTM mapping specifications. Lead or assist with review of trial-specific eCRF and SDTM deliverables to ensure compliance with CDISC (CDASH / SDTM) and applicable company data standards. Lead or assist with development of User Acceptance Testing (UAT) plans. Coordinate and/or participate in execution of UAT. Oversee reconciliation of external data sources. Partner with Pharmacovigilance colleagues to perform reconciliation of serious adverse events and other trial-specific events, as required. Proactively organize and facilitate holistic data review by the Indivior team throughout the conduct of trials to ensure timely and appropriate identification of trends, anomalies, and quality issues. Ensure proper closeout and archival of Data Management trial documentation, as required by the trial-specific Trial Master File Oversight Plan. Ensure compliance with all applicable laws, regulations, and regulatory guidelines. Understand and follow applicable Indivior SOPs / Work Instructions / Forms. Review and provide input into the development and implementation of Data Management and related SOP / Work Instructions / Forms.TRAVEL
Less than 10% travel.
MINIMUM QUALIFICATIONS
Minimum of Bachelor’s degree with 7 years of experience or Master’s degree with 5 years of experience as a Clinical Data Manager in the pharmaceutical or biotech industries. Strong knowledge in all aspects of Clinical Data Management. Advanced knowledge of and experience using EDC platforms/Clinical Data Management Systems (Medidata Rave preferred) and Centralized / Risk Based Monitoring. Knowledge of medical terminology, MedDRA and WHODrug dictionaries, and database design concepts. Working knowledge of ICH, FDA, CFR, GCP, HIPAA, GCDMP regulations and guidelines. Working knowledge of and experience implementing CDISC CDASH / SDTM / ADaM standards.COMPETENCIES/CONDUCT
In addition to the minimum qualifications, the employee will demonstrate:
Excellent project management and organizational skills with great attention to detail and the demonstrated ability to successfully manage multiple trials concurrently. Excellent verbal and written communication skills, including proven abilities in cross-functional collaboration, cooperation, and building relationships. Demonstrated vendor management skills. Proven ability to work proactively, efficiently, and effectively in a fast-paced environment. Flexible, well-organized, and works well under pressure and amid changing priorities. Proven excellence in operational strategy; experience with developing and implementing operational processes and systems. Excellent problem-solving, organizational and negotiating skills. Ability to interact effectively across boundaries with other functions and disciplines using influencing, communication and relationship building skills.BENEFITS:
Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:
25 days holiday plus public holidays Flexible working; core hours are 10am-3pm, and we offer upto 2 days working from home/ week for office based roles, as well as a flexible Friday programme, subject to completion of contractual hours. Paid Volunteer Time Off 10% company pension EAP service including Legal, Health and Wellbeing support Optional Health Insurance with BUPA Company Death in Service and Payment Protection Insurance Access to platform for discounts on such as gym membership, shopping, holidays Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.-
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