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Proj Manager, Data Management

US-Texas-San Antonio, IDS
Permanent
Reference: 045415
This vacancy has now expired.
Description
Project Manager, Data Management   (for IEP)
 
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.  Responsible for managing data management teams, studies and programs of studies under the general direction of the Director or Sr.  Manager of Data Management.  
Provide planning estimates for project scope, schedule, and resource requirements insuring programs are properly budgeted, estimated, and scheduled.  
Work with Clinical Operations, CDMS, Biostatistics, CDS, ITG, Medical Writing, Regulatory Affairs and Quality Assurance to ensure that data collected during trials are managed according to corporate standards and meet regulatory guide lines for data integrity.    
Overview of the Role  
  • Recognize exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
  • The employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
  • Travel (approximately  15%) domestic and/or international.
  • Manage a Data Management team, study and or program of studies to ensure project objectives are met within budget, to agreed timeline and to high level of quality.
  • Develop and foster sponsor relationships through effective project management and communication.
  • •Represent or offer significant contributions to the representation of data management on specific sponsor partnerships and/or alliances provide regular status reports and KPls to senior management and represent Data Management at oversight meetings.
  • Represent Data Management at internal and external audits and manage findings through resolution both operationally and within the Quality Management System.
  • Lead, coordinate or participate in the design, development and implementation of departmental and company Initiatives.
  • Provide input into CRF design, protocol review, edit check specifications, data entry conventions, monitoring guidelines, and any other study related documents, as required.
  • *Direct, lead, or perform the development, validation, and User Acceptance Testing of the clinical data management system database and associated edit checks.
  • *Direct, lead, or perform all Data Management data processing, data reconciliation, query generation and resolution, cleaning, medical coding, quality review tasks, database close/lock, and relevant archiving of study materials.
  • *Resolve issues for assigned projects related to quality, project delivery, compliance, and/or client relationships and satisfaction.
  • Actively  participate in Business Development presentations to sponsors as required.
  • Assist Business Development colleagues with the preparation of Data Management bids as required.
  • Provide other general duties as required to support the company.
  • Effectively manage work priorities, delegating responsibilities where appropriate Monitors compliance to ensure studies are in line with internal quality Initiatives and that they are inspection ready.
  • Acts as mentor to all junior staff levels.  
 
Role Requirements  
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • US/LATAM/CAN: A minimum of 8 years clinical data management experience.
  • Appropriate experience and understanding of at least one clinical data management system (e.g. RAVE, INFORM, OCRDC)
  • Knowledge of FDA regulations and all relevant local or regional regulations respecting data quality and clinical trials conduct.
  • Strong written and oral communication skills.
  • Proven leadership skills.
  • Capability to work within a team environment
  • Capability to manage competing priorities in a changeable environment.
  • Capability to handle stressful situations and deadlines.
  • Knowledge of relevant CDISC standards, such as CDAS H and SDTM, is preferred.
  • Prior experience with successfully leading clinical data management project team is strongly preferred.
  • Ability to liaise successfully with project teams and sponsors, including excellent written and verbal communication skills.
  • Excellent interpersonal skills.
  • Due to the nature of this position, it may be required for the employee to travel. Therefore, dependent on the employee's location, the employee may be required to possess a valid Driver's license.
  • Bachelor degree or local equivalent in a scientific discipline and/or appropriate experience.
 
Benefits of Working in ICON
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.   
 
What’s Next?
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
 
ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.
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