Data Management Assistant

Career Level- H2

Data Management Project Assistant

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.

1. PURPOSE OF THE JOB:

• . To assist in the preparation, maintenance of project related study files and documents in accordance with ICON Standard Operating Procedures (SOPs), Sponsor and ISO requirements.
• To provide assistance to the project team in support of Data Management activities.

2. JOB FUNCTIONS/RESPONSIBILITIES:

. Recognise, exemplify and adhere to ICON's values which centre around our commitment to People, Clients and Performance
* Assist in the preparation and maintenance of project related study files and documents.
• Assist in the set-up and maintenance of project related study documentation and study files both electronic and hard copy versions as applicable.
• Ensure SOP and/or Study Specific Procedure (SSP) compliant document storage by accurately filing study related material. This may include Central File support for Data Management as necessary.
• Assist with the coordination and completion of project related closeout activities as defined by ICON and/or Sponsor SOPs/SSPs. This may include tracking, returning and archiving study related documentation.
* Provide assistance to the project team in support of data management activities.
• Provide support to the project team for Case Report Form/Query processing according to SSPs as appropriate.
• Accurately perform Quality Reviews and appropriately identify all issues as necessary.
• Accurately complete and submit weekly project timesheets as directed by company policy.
• Perform other duties reasonably related to the position as directed by manager/designee.




3. QUALIFICATIONS/EXPERIENCE REQUIRED:

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.

Education and/or Experience:

Minimum High School or Diploma / Degree and 1 year relevant work experience.

Technical Requirements and Competency:

Required:
Proficient in MS Office. (i.e., Word, EXCEL, Access)
General office experience defined as filing, faxing, copying and archiving.
Familiarity with Data Management processes and/or one Clinical Data Management System.
Understanding of ICH/ GCP Guidelines regarding data quality and clinical trials conduct.
Understanding of ISO requirements including standard operating procedures.

Preferred but not required.

Competency:
Ability to read, understand and accurately interpret procedures for all job related tasks.

Behavior Competency:

Excellent accuracy, attentiveness to detail and capacity to maintain a high level of quality in work related tasks.
Strong organizational and time management skills.
Ability to work within a team environment and maintain a constructive approach when responding to internal customers.
Ability to identify process inefficiencies and proactively communicate to management strategies for improvement and development.
Ability to respond with flexibility to changing priorities in a fast paced environment.
Professional written and oral communication skills.
Professional approach to the work environment.

Physical Requirements and Work Environment:

The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job the employee may be required to sit at a desk and utilize computer equipment for an extended length of time.
The use of a stepladder and electronic mobile shelving units may be required during filing and archiving.
The employee may occasionally lift and/or move up to 40 pounds or other specified weight as identified per region.
The noise level in the work environment is considered quiet.

Benefits of Working in ICON
Other than working with a great team of smart and energetic people, we also offer a very competitive salary and benefits package that includes an excellent pension scheme, private health care, life assurance and staff recognition schemes. 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.