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 Clinical Data Manager (CDM) is responsible for managing a team of data analysts, assistants and/or statisticians working closely with the Bracket Practice Leaders, Therapeutic Area Leaders, Project Teams, Clinicians, and the Technical Delivery teams to address data analytics, data transfers, and data management business needs and translate them into system requirements.
Essential Duties and Responsibilities:
Note: Other duties may be assigned.
The Clinical Data Manager will play a role in the following functional capacities:
Manage Data Analysts, and other resources as assigned; provide ongoing career development, mentoring and performance feedback.
Understand the data analytics 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.
Liaise with project teams, Therapeutic Area Leaders, and Practice Leaders to gather sponsor-requested custom reporting requirements and translate them into technical requirements.
Develop Data Transfer Plans or Agreements (DTPs/DTAs), coordinating with external data management teams to align with system-specific requirements
Manage creation of report standards and templates to be utilized across project teams.
Lead teams to elicit, analyze, verify and document data analysis and reporting requirements for all clinical data quality services (i.e. rater training, endpoint reliability, cognition, etc.).
Lead teams to create Data Management Plan (DMP) for all active projects; assist in documenting data management requirements and provide support for all sponsor questions related to data management
Handoff technical requirements to Product Innovation and Technical Delivery resources, collaborating on design, development, and testing, ensuring all parties clearly understand requirements.
Own updates to Standard Operating Procedures and delivery guidelines for all data management and data analytics activities.
Train project teams on new data management and data analytics procedures and client communications.
Responsible for coordinating User Acceptance Testing (UAT) for new reports including execution of test scripts when necessary; Responsible for tracking issues and resolutions throughout the testing process.
Create UAT scripts as needed for custom reports and data transfers
Coordinate with Client Services Project Managers to ensure all project expectations are met.
Monitor direct report activity and report weekly to Leadership.
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.
At least two (2) years Data Management and/or related work experience in a medical device or pharmaceutical industry/company
Experience with managing resource allocation and delivery management.
Experience gathering requirements, developing, and validating reports or Data Transfer Agreements.
Knowledge of GCP and FDA guidelines for clinical trial data management
Working knowledge of CDISC requirements
Preferred professional experience with statistical software applications such as R, SAS, etc.
Preferred professional experience within the pharmaceutical industry. CNS clinical trials experience preferred. Training and/or education background valued.
Competencies & Personal Attributes
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.