Senior Clinical Data Manager
Beacon Hill Pharma Remote, OR
- Posted: over a month ago
- Benefits: medical, vision, dental,
A highly reputable pharmaceutical company is hiring a qualified Senior Clinical Data Manager to work remotely in the United States.
- Highly motivated professional to successfully manage and oversee data management activities for global clinical trials.
- Integral member of the biometrics team whose work enables the company to meet defined goals for the clinical development programs.
- Responsible for the execution and oversight of CROs’ data management activities utilizing best practices in order to ensure budgets, timelines and performance requirements are met.
- Responsible for coordinating all data management efforts for the trials, both within the company and through a wide variety of vendors.
- Collaborates with other functional peer groups at various management levels and senior management to ensure proper conduct and timely completion of all projects, as applicable.
Role and Responsibilities:
- Oversight of all data management activities and deliverables on assigned clinical studies
- Manage and oversee CROs handling clinical data, including managing their timelines and budgets
- Work with CROs and Medical Monitors to coordinate activities for the medical review of clinical trial data
- Work with biostatistician and SAS programmers to ensure CDISC data standards (CDASH/SDTM) are implemented
- Provide review and oversight of database design, UAT, and deployment to ensure quality and efficiencies through data and process standardization
- Participate in cross-functional team meetings and communicate regarding project status/issues and timelines (including study database lock and data reviews), and provide feedback to CRO
- Oversee the development of data management documents (e.g., Data Management Plans, edit checks, data validation specifications, data transfer agreements)
- Lead interactions between company and external data vendors on the collection, transmittal, and transfer of clinical trial data; support review and reconciliation of external data; coordinates/leads SAE reconciliation
- Review clinical study protocols and statistical analysis plans and ensure data quality for data analyses
- Ensure regulatory compliance of vendors and investigational sites with company SOPs, FDA and ICH guidelines, and other applicable regulations and guidelines, as they pertain to data management activities
- Manage competing data management priorities across multiple studies
- Work independently, exercise appropriate judgment, and coach other team members for effective communication
- Assessment of data management vendors
- Assist in the compilation of clinical data for regulatory submissions
- Previous experience in the management of budgets
- In-depth knowledge of all aspects of data collection and query resolution in clinical studies
- Strong working knowledge of GCP, CDASH, and CDISC data structures, 21 CFR Part 11, ICH guidelines, and FDA regulations
- Working knowledge of data management software (EDC, IXRS, ePRO, and other remote capture systems used in the industry)
- Knowledge of EDC systems(e.g., Oracle Inform, Medidata Rave), Argus platform, and general understanding/use of SAS
- Demonstrated capabilities and proven track record of problem-solving skills
- Excellent communication skills (oral and written) and interpersonal skills
- Ability and willingness to travel up to 10% of the time, including domestic and international travel
- Highly motivated team player willing to work and collaborate cross-functionally
Job Requirements and Education:
- Bachelor’s Degree in data management or related field of study preferred
- Oncology therapeutic area experience preferred
- Minimum of 4+ years data management (with Bachelor’s degree) or 6+ years data management (without Bachelor’s degree) experience in the pharmaceutical/biotech/CRO industry
- Direct experience in oversight of data management vendors
Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.
Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.
Beacon Hill PharmaWhy Work Here?
Opportunity for growth. Great company culture.
Beacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations. Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S. Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.
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