Associate Clinical Data Manager
Signant Health
Iasi, RO
4 zile în urmă

Role Overview

The Associate 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.

    Key Accountabilities / Decision Making & Influence

  • Develop and maintain the Data Management Plan (DMP).
  • Develop and maintain study-specific Data Cleaning / Reconciliation reports and validation plans.
  • Provide weekly data management status updates to the clients and internal Project Managers.
  • Work with internal Delivery team to define data management timelines to ensure DM milestones are met.
  • Develop other study-specific documentation manuals including but not limited to the Maintenance Guide (MG) as necessary.
  • Conduct study-specific trainings with internal Data Coordinators and Data Reviewers prior to release of the Data Management Plan initiatives
  • Adhere to CRF Health Standard Operating Procedures for all data management responsibilities.
  • Identifies areas of opportunity for improvement in the end to end process of Data Management, driving out waste, increasing productivity and delivering quality
  • Collaborate with clients and internal Delivery teams to develop and maintain protocol specific monitoring report specifications.
  • Collaborate with clients and internal Data Coordinators and Data Reviewers to generate a study-specific tool for flagging discrepancies between the client IVR / EDC and TrialManager outputs.
  • Collaborate with clients and internal Technical Client Services team in order to conduct protocol reviews to identify protocol specific device design and eligibility criteria.
  • Diversity and Inclusion Competencies

    FOR MANAGER ROLES :

  • Emphasis on removing bias in decisions related to promoting, hiring, leading, training and coaching team members.
  • Advocate for diverse perspectives and model inclusive behavior.
  • Influence others to promote, embrace and progress an inclusive environment.
  • FOR ALL ROLES :

  • Dedication and commitment to promote diversity, multiculturalism and inclusion in all work activities
  • Ability to collaborate in diverse teams to foster productive outcomes.
  • Knowledge, Skills & Attributes

  • BA / BS degree in a relevant field (Medicine, Statistics, Computer Science) or equivalent work experience
  • Technical aptitudes and ability to complete high quality technical documentation. Ability to understand and work with HTML as well as different types of clinical databases.
  • Demonstrate extreme attention to detail and organization in all aspects of work. Previous project management experience is an advantage.
  • 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.
  • 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.
  • Strong verbal and written communication skills
  • At Signant Health, accepting difference isn’t enough we celebrate it, we support it, and we nurture it for the benefit of our team members, our clients and our community.

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