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 Associate Director, eCOA Clinical Data Management is responsible for managing a team of Data Managers, Data Analysts, and Clinical Programmers. The Associate Director will work closely with the Technical Delivery, Product Innovation, Client Services and Product Implementation eCOA teams to address Data Extracts, Data Transfers, and Data Management business needs and translate them into system requirements compliant with federal and international regulatory standards.
Essential Duties and Responsibilities:
Note: Other duties may be assigned.
The Associate Director, eCOA Clinical Data Management will play a role in the following functional capacities:
Understand the Data Management and Reporting business processes across the entire organization, identify gaps, weaknesses and potential efficiencies in Data Management and Reporting and report as appropriate
Work closely with other departments to ensure effective collaboration with respect to design, development, testing and launch of internal and client facing systems to optimize system stability. Develop and/or refine process improvements that reduce processing times, increase quality, mitigate operations risks, improve team performance, and meet departmental objectives and corporate objectives
Ensure that Bracket’s Data Management processes are GCP and regulatory compliant
Collaborate regularly with Total Quality Management to incorporate necessary changes resulting from direct Corrective and Preventive Action (CAPA) investigations into system requirements
Liaise with Technical Delivery and Data Analysts in gathering sponsor-requested custom reporting requirements and translate them into technical requirements as needed
Develop Data Transfer Plans or Agreements (DTPs/DTAs), coordinating with external data management teams to align with system-specific requirements
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
Manage Data Analysts, and other resources as assigned; provide ongoing career development, mentoring and performance feedback
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, Working Instructions and delivery guidelines for all Data Management and Data Analytics activities
Train project teams on new Data Management procedures and client communications
Create report specifications as needed for custom reports and data transfers
Coordinate User Acceptance Testing (UAT) for new reports including execution of test scripts when necessary; responsible for tracking issues and resolutions throughout the testing process
Enhance the Bracket business model by institutionalizing business processes, implementing best practices and templates, and seeking ways to work more efficiently
Serve as the SME with regard to Sponsor projects, attending client calls as needed
Serve as the Bracket authority and collaborate with Business Development on RFP responses and bid defenses
Skills & Competencies
College degree in Data Management, Computer Science or IT related field (B.S., B.A.)/University Degree for EU candidates.Demonstrated experience will be considered in lieu of degree.
At least three (3) years Data Management and/or related work experience in a medical device or pharmaceutical industry/company
Experience with electronic data capture systems in the field of healthcare or research
Knowledge of GCP and FDA guidelines for clinical trial Data Management
Working knowledge of CDISC SDTM Formats
Audit experience in Clinical Trials
Working knowledge of SQL
Experience with managing resource allocation and delivery management
Experience gathering requirements, developing, and validating reports or Data Transfer Agreements
Preferred professional experience with statistical software applications such as R, SAS, or Stata
Preferred professional experience within the pharmaceutical industry.CNS clinical trials experience preferred.
Training and/or education background valued
Strong service orientation for internal and external teams
Strong ability to collaborate and be accountable
Proven ability to analyze complex business problems and develop technical solutions that meet the business needs
Must have excellent written communication skills, including the ability to effectively document procedures, processes and results
Demonstrated ability to meet deadlines & multi-task in a fast-paced work environment
Demonstrate extreme attention to detail and organization in all aspects of work
Must have very strong skills with Microsoft Office applications
Must be comfortable working with business users and technical teams
Familiarity with SQL
Knowledge of GCP and 21 CFR Part 11
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.