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Job Details

Senior Clinical Data Manager

Company: SynteractHCR Deutschland GmbH
Location: Morrisville, NC
Reference: 27222
Closing Date: 16 Jan 18
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

Overview   The Senior Clinical Data Manager is responsible for managing the clinical trial data for multiple assigned projects; acts as liaison between Company personnel and Sponsor personnel to implement and maintain clinical databases.  S/he presents project-related or software-related training; coordinates activities such as medical coding, electronic data transfer, and all other aspects of data clean-up.

Requirements:

Overview

 

The Senior Clinical Data Manager is responsible for managing the clinical trial data for multiple assigned projects; acts as liaison between Company personnel and Sponsor personnel to implement and maintain clinical databases.  S/he presents project-related or software-related training; coordinates activities such as medical coding, electronic data transfer, and all other aspects of data clean-up.  May delegate tasks/responsibilities to multiple team members in multiple projects.  Provides project oversight of daily, weekly and monthly data management tasks and Sponsor deliverables to ensure assigned projects and deliverables are on track.  Additionally, s/he will serve as a technical resource to colleagues; troubleshoot technical problems; manage more complex projects.

 

Responsibilities

  • Designs, or directs the design of, a Case Report Form (CRF) for data collection.
  • Coordinates the printing of CRFs, if applicable for the project.
  • Coordinates CRF/Data Clarification Form (DCF) tracking, if applicable for the project.
  • Develops a Data Management Plan (DMP), outlining all data management responsibilities.
  • Designs, or directs the design of, an efficient logical database using the Company’s standards or the Sponsor’s specifications, which can be exported efficiently into SAS.
  • Defines, validates, and documents logical edit checks for data quality control. May program database edit checks.
  • Responsible for conducting and documenting project-specific training for all team members prior to project start and throughout the course of the project, as needed.
  • Responsible for training end users on the applicable Clinical Data Management System, maintaining current system access and ensuring all training records are up to date.
  • Responds to inquiries and provides guidance to study team to ensure accuracy of data. Able to assess skill set of team members to provide individual training and appropriately QC the work performed on an ongoing basis.
  • Ensures completion of a comprehensive data review.
  • Verifies, or supervises verification of, data entry, processes edit checks, query resolutions and data clarifications.
  • Communicates with the Sponsor as needed regarding data/database issues. Responds to any requests or needs of the Sponsor during the course of the project.
  • Understands the sequence of running SAS programs to ensure up-to-date data and to troubleshoot problems.  May use SAS to develop, program and maintain any output needed within the Data Management group.  Able to use SAS to review clinical datasets.
  • Produces reports, listings and other output as required during the course of the project.
  • Exports data from the clinical database to update the SAS database.
  • Creates, or directs the creation of, subject profiles to verify the data entry of paper CRFs.
  • Ensures medical coding is performed in a timely manner, as directed by the DMP.
  • May perform coding of medical terms/medications.
  • Receives electronic data and prepares it for use by Programming/Biostatistics. Performs reconciliation of the external data against the CRF. Interacts with vendors to resolve discrepancies.
  • Ensures that all project documentation is complete, accurate and reviewed by the appropriate personnel on an ongoing basis.
  • Conducts and documents the database closeout, reviews subject profile findings and provides relevant documentation to the Sponsor and the Company’s appropriate senior management members.
  • Archives project documents.
  • Able to accept responsibility for projects transitioned to the Company mid-project, clean up the database, the data, and the documentation.
  • Assists in writing/reviewing/updating Data Management related Standard Operating Procedures (SOPs).
  • May prepare and present data management topics to the department.
  • May present software demonstrations and/or project-specific CRF instructions at Sponsor meetings or bid defenses.
  • Provides operational and technical guidance and direction to colleagues.

     

Qualifications

Academic & Professional Qualifications:

  • Bachelor’s degree in a related field of study and 5+ years leading studies or equivalent combination of education and experience.  

Skills & Experience:

  • Completion of a Clinical Trials certification program is an asset.
  • Proficiency in Microsoft Office; Word, Excel, PowerPoint, Outlook as required.
  • Effective verbal and writing skills; English + local language, if relevant.

     

 

What We Have to Offer

Our team-oriented organization is collaborative and diverse; our work is interesting and challenging; and every individual has an opportunity to thrive, grow, and achieve success in his or her position. We are proud of our reputation in the industry for quality services and specialized teams dedicated to meeting or exceeding client expectations

 

Who We Are

Synteract is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. With our “Shared Work – Shared Vision” philosophy we provide customized Phase I through IV services collaboratively and cost effectively ensuring on-time delivery of quality data so clients get to decision points faster. Operating in 15 countries, we deliver trials internationally, offering expertise across multiple therapeutic areas including notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications.

 

Our mission is to support the innovation and development of better therapies in healthcare. Our focus on patients’ safety and comfort helps us to establish ethical standards for everything we do.

 

Synteract’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire.

 

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Contact Information:

Address:  SynteractHCR Deutschland GmbH
Albrechtstrabe 14
80636 Munich
Germany
Tel:  +49 89 12 66 80 0
Fax:  +49 89 12 66 80 2444
Website:  Visit Our Web Site

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