Clinical Data Manager - Anywhere US

Synteract - USA - Clinical Data Manager - Anywhere, US Remote Who We Are Synteract ® , a Syneos Health ® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. We provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases. Position Overview As a Clinical Data Manager (DM) you will be responsible for the coordination and delivery of Data Management contracted services on assigned projects. This includes meeting internal and external sponsor requirements according to time, quality, scope and budget parameters. You will be the primary point of contact for Data Management on a project, for internal project team members, sponsors, and external data vendors. You will present project-related training and may provide technical guidance and direction to team members. Specific tasks would include: Serves as the primary Data Management interface for internal project team members, sponsor representatives, third party CROs and external data vendors. Ensures the timely initiation, conduct and completion of Data Management activities on clinical trials. Leads a sub-team of Data Management staff members assigned to a project. Tracks Data Management timelines for assigned projects and ensures that all applicable Data Management team members are aware and on target for deliverables. Authors the Data Management Plan (DMP), outlining all data management responsibilities. Authors the Data Transfer Agreement (DTA) with third party external data vendors Oversees UAT of clinical data systems (EDC, eCOA, IWRS) to be implemented on a project. Conducts project-specific training throughout the course of the project, as needed. Attends and presents at client bid defense meetings. Attends and presents at project meetings as required. Oversees the completion of a comprehensive data review of clinical data. Ensures medical coding is performed in a timely manner. Ensures DM documentation is audit-ready and filed appropriately at all times. Coordinates all activities in preparation for database lock, including Data Review Meeting. Produces status or progress reports, listings, and other output as required during the course of the project. Monitors budget and scope of work for contracted DM services throughout the duration of the project, identifying out of scope or budget activities and collaborating with the project manager when out of scope documentation and costs are needed. Qualifications Bachelor's degree in a related field of study or equivalent combination of education and work experience. Minimum 2 years experience in a lead role. Business development experience preferred. CRO experience preferred. Specific Knowledge Knowledge of ICH/GCP standards, 21 CFR Part 11. Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook. Effective verbal and writing skills; English + local language, if relevant. This job excludes Colorado applicants. If you're passionate about bringing clinical trials to life, we encourage you to apply today! Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.... - Permanent - Full-time

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