Data Manager/Senior Data Manager

This position is important to the overall operation of Promedica International.

This position reports to the Director, Clinical Services and Data Management. This position is responsible for study data.

This position may involve up to 10% of travel and requires a person who works effectively with clinicians, allied healthcare personnel, clients, vendors, and Promedica International staff by:

Sharing ideas in a constructive and positive manner

Listening to and objectively considering ideas and suggestions from others

Keeping commitments

Keeping others informed of work progress, timetables and issues

Addressing problems/issues constructively to find mutually acceptable solutions

Addressing others by name, title or other respectful identifier

Respecting the diversity of our work force in actions, words, and deeds

Duties of this position may be described in the following functions below. This description is representative, but not all-inclusive, based on the company’s growth.

Accountability/Responsibilities

Project and General Management/Administration

Interfaces with clinical Project Manager(s) and statistician(s) to establish project data management plans and requirements, and database implementation schedules and other key study documents

Interfaces with IT Manager, Project Manager, and Software Developer to review project database implementation schedules, database utilization training, and database utilization efficiency
Participates in the department project clinical data system design, utilization, and maintenance to maintain conformance with FDA guidelines for clinical data management

Review protocols for CRF design and creation and develop electronic CRFs for use in clinical data management systems

Collaborate with biostatisticians in the creation of analysis datasets

Perform database quality assurance audits and database locks
Create test data and perform user acceptance testing on new databases

Establishes and maintains department Standard Operating Procedures for data management activities. Works with Quality Systems Manager and/or Administrator to revise, develop, or implement new procedures as required

Provides recommendations for improvement of project or divisional efficiencies based on work experience and observations

Participates in project review meetings as requested

Participates in business development proposal team and presentations as needed

Participates in budget maintenance for project data management-related activities

Experience/Skills Recommended for Position:

Proficiency in Data Management Plan development and maintenance
Experience with study start up tasks, CRF design, database development, edit check creation, eCRF completion guidelines, validation and user acceptance testing
Database build experience
Thorough understanding of FDA, ICH and GCP regulations and guidelines regarding management of data for clinical studies
Familiarity with current data standards (e.g., XML/CDISC) and database administration
Proficiency with EDC systems, Word, Excel, Access, PowerPoint, and Outlook, as well as web-based software systems. Understanding of SAS, Microsoft SQL
Knowledge of programming in SQL reporting using Microsoft SQL Reporting Services and Crystal Reports desirable.
Understanding of coding process and dictionaries
SAE Reconciliation and external data reconciliation experience
Strong communication skills as demonstrated via telephone interactions, personal presentations, and general written correspondence.
Well-organized, with strong attention to detail, documentation, and follow-through. Ability to work on multiple tasks simultaneously.
Leadership skills, and ability to work effectively within a team configuration
Willingness to both lead studies and complete data management review activities
Pharma and medical device experience preferred
5+ years experience in data management
BS or BA degree