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Clinical Data Manager

Department: C-US-SciSvc-Tech Delivery
Location: Wayne , PA

Looking for the right company?

Bracket

Science. Technology. Service.

Bracket offers a unique suite of solutions, with a unique perspective on clinical research development. We focus on bringing together best-in-class science, technology and service to drive superior clinical outcome results for our clients and for their patients. 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!

 

Is this job right for you?

The Clinical Data Manager is responsible for working with the Clinical Data Management team and other internal project team members to provide data management services for our customers to ensure on time and accurate deliverables. Responsibilities include providing data management guidance to internal project team members and customers; communicating with internal project team members and customers on all aspects of data management activities performed for a study; authoring data management documents; performing user acceptance testing on data management deliverables; and facilitating and verifying data clarifications and data changes.

Essential Duties and Responsibilities:

Note: Other duties may be assigned.

  • Collaborate across functional groups to address technical issues impacting quality, drive forward technical initiatives within Data Management
  • Provides data management guidance to internal project team members and customers
  • Communicates with internal project team members and customers on all aspects of data management activities performed for a study
  • Authors data management plans (DMP)
  • Authors data transfer specifications (DTS)
  • Performs user acceptance testing on reports specified in the DMP
  • Performs user acceptance testing on automated data checks programmed to support the data cleaning activities specified in the DMP
  • Reviews, makes decisions, and acts upon output from automated data checks
  • Facilitates risk assessments for mid-study changes
  • Verifies data extracts against the DTS
  • Provides proactive data monitoring per contractual obligations
  • Facilitates and verifies data clarifications and data corrections
  • Facilitates and verifies external data reconciliation
  • Contribute to the development and update of process improvements that reduce processing times, increase quality, mitigate operations risks, improve team performance, and meet departmental objectives and corporate objectives
  • Communicates effectively within a multi-disciplinary project team to complete assigned tasks on time and within budget
  • Performs all work in accordance with documented Standard Operating Procedures (SOPs), Working Instructions and Best Practices
  • Assists in developing and improving Standard Operating Procedures (SOPs), Working Instructions and Best Practices
  • Enhance the Bracket business model by institutionalizing business processes, implementing best practices and templates, and seeking ways to work more efficiently
  • Participates in special data-related projects as needed
  • Assist with other departmental initiatives and projects as required

 

Do you have the right background for this job?

Required Skills and Experience

  • BA/BS degree or equivalent work experience
  • 3+ years of professional experience in the clinical trials data management field
  • Experience in providing data management services in the clinical trials industry
  • Proficient in Access, Excel, and other office software technologies and applications.
  • Proven ability to handle multiple competing priorities in a fast-paced work environment with minimal direct supervision.
  • Familiarity with 21 CFR Part 11 or experience in a regulated environment desirable

Competencies & Personal Attributes

  • Strong verbal and written communication skills
  • Ability to complete high quality technical documentation
  • Demonstrate extreme attention to detail and organization in all aspects of work
  • Ability to quickly learn and apply new skills, procedures and approaches.
  • Demonstrated ability to meet very short deadlines & multi-task in an extremely fast-paced work environment with little direct supervision
  • Proven ability to work both independently and in a team-oriented environment, providing back-up support to team members & establishing/maintaining effective work relationships with co-workers within and across functional areas
  • Previously demonstrated proactive and positive approach to tasks and projects overall, as well as to the types of scheduling & process changes that are inherent in a fast-paced business

 

We treat our employees right:

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 benefits.

Bracket is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will be considered for employment regardless of race, religion, gender, gender identity, sexual orientation, national origin, disability, age, or veteran status. Bracket is also committed to complying with all fair employment practices regarding citizenship and immigration status.

The right opportunity is waiting for you here at Bracket, what are you waiting for? Apply now!

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