Science. Technology. Service.
Bracket innovates at the leading-edge of clinical research data, one exceptional service at a time. From the advanced technology of our eCOA electronic Clinical Outcomes Assessments flexible platform, to the efficiency of our scalable and configurable Randomization and Trial Supply Management (RTSM) Clinical IRT solution, to our science-focused Rater Training and Quality Assurance programs, Bracket does it faster, better and with an eye on the future of our industry. To achieve this, we maintain an unwavering commitment to employing only the brightest, most talented colleagues gleaned from a wide variety of professional fields. If you are a creative problem-solver and have a hard-wired, instinctual commitment to exceptional customer service, we'd love to talk to you!
The Data Manager, eCOA Data Management is responsible for ensuring data management activities are completed with quality and on schedule within the eCOA services (ePRO/eClinRo). Oversees service providers to perform core data management functions including but not limited to study build consultation, data management plans, data transfer agreements, data quality checks, standard/ad-hoc report specification, validation and study closure during the course of a project lifecycle (PLC) . This position will work closely with Bracket Practice Leaders, Therapeutic Area Leaders, Project Teams, Clinicians, and the Data Management Analysts to address both data analytic and data management business needs and translate into system requirements. This role will also be responsible for defining and maintaining department standards and producing metrics to support internal operations
Essential Duties and Responsibilities:
Note: Other duties may be assigned.
The Data Manager, eCOA Data Management will be responsible for the following functional capacities:
Primary liaison between internal and external customers for all Clinical Data Management activities and communication.
Lead & coordinate across functional teams to create Data Management Plan for all projects; documenting data management requirements and providing support to internal and external customers for all topics related to data management lifecycle with focus on data quality and integrity.
Lead & coordinate across functional teams to create Data Transfer Specifications for all projects; documenting data transfer agreements and or working with sponsors standards to support and ensure quality and integrity of data during the transfer lifecycle process.
Lead & coordinate across functional teams to create Ad-hoc Reporting Specifications for all projects; documenting specifications/requirements translating into technical documentation to support programming and validation for reports, either for internal or external use.
Lead & coordinate across functional teams to create Quality Check Specifications for the purpose of cleaning data for all projects; documenting requirements into technical documentation to support internal project & clinical teams for data quality review.
Understand data analytic concepts and reporting business processes across the entire organization, identify gaps, weaknesses and potential efficiencies in Data Analysis and Reporting and report those to Data Analytics Leadership.
Manage creation of Data Management standards and templates.
Assist with develop and Maintenance of Standard Operating Procedures and delivery guidelines for all data management and data analytics activities.
Coordinate with Client Services Project Managers to ensure priorities are defined and project expectations are met.
Maintain and monitor the status of Data Management activities.
Enhance the Bracket business model by institutionalizing business processes, implementing best practices and templates, and seeking ways to work more efficiently.
Skills & Competencies
College degree (B.S., B.A.)/University Degree for EU candidates or equivalent years of experience.
Four to six years of professional experience.
Two to four years of clinical trial experience in data management or project management.
Experience liaising between clinical, operational and technical personnel both internal and external to gather requirements, author technical documents and manage change control.
Demonstrable knowledge and understanding of relational database structure.
Knowledge of GCP and FDA guidelines for clinical trial data management.
Knowledge of industry guidance and standards for data collection and tabulations such as CDISC SDTM and CDISC Questionnaires, Ratings and Scales (QRS).
Experience with eCRF systems, eCOA, ePRO data capture systems.
Programming experience/familiarity with SAS, SQL and/or R is a plus.
CNS clinical trials experience preferred. Training and/or education background valued.
Proven ability to analyze complex business problems and develop technical solutions that meet the business needs.
Must have excellent analytical skills with proven ability to comprehend business requirements.
Experience with managing work plans and deliverables.
Comfortable working with business users and technical teams.
Demonstrated experience interfacing, influencing and negotiating with business users and technical teams.
Understanding of database reporting and functionality.
Must have excellent writing and communication skills.
Must have very strong skills with Microsoft Office application to include the following: Word, Excel, Access, Visio and PowerPoint.
Ability to manage own time proactively identify prioritized tasks.
Entrepreneurial spirit, drive and work ethic.
Focus on attention to detail.
We offer a fully comprehensive benefits program with medical, dental, vision, company paid life insurance, short and long term disability. Great Paid Time Off program that starts with 20 days of accrual per calendar year; great 401k plan with company match that is 100% vested immediately. Paid parental leave and other competitive benefit programs. Great salary and reward and recognition programs.