Clinical Data Manager

Employer
Advanced Clinical
Location
Romania
Salary
Competitive
Closing date
4 Oct 2020

View more

Discipline
Data Management / Statistics, Clinical Data Management
Hours
Full Time
Contract Type
Permanent
You need to sign in or create an account to save a job.

Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there's no better place to grow your career than Advanced Clinical.

A Clinical Data Manager (CDM) is responsible for the Data review, User Account Management, QC activities and other data review tasks for a clinical study.
  • Follow Standard Operating Procedures (SOPs).
  • Perform DM Review.
    • Review eCRFs in the clinical database to ensure data is consistent and complete utilizing the DMP and ECS.
    • Perform manual review as listed in the ECS.
      • Identify data discrepancies outside of the ECS and communicate manual queries where necessary to applicable data management personnel.
    • Perform Vendor Data Reconciliation with applicable clinical database (e.g. IVRS, laboratory data, SAE).
      • Identify potential queries and communicate findings to applicable personnel.
    • Address answered queries, identify any re-queries needed, and communicate to applicable data management personnel.
    • Track all DM issues and ensure proper resolution by study completion.
    • Identify data trends and report inconsistencies to applicable data management personnel and work together to develop and implement an action plan.
    • Identify the achievement of milestones and report to the applicable data management personnel.
  • Perform User Account Management.
  • Perform data entry or quality control review of Laboratory Normal Ranges
  • Perform archival of study data from EDC system.
  • Additional responsibilities
    • May Perform 1 st and 2 nd pass entry following the DMP and client conventions, if applicable.
    • Assist in the creation and review of SOPs and training materials.
    • Ad hoc report creation.
    • Conduct training for employees.
    • Perform other duties as requested by management.

A Bachelor's Degree is required. The candidate must be able to perform all job functions after minimal direct supervision. The candidate must have excellent written, verbal and organization skills. They must be detail-orientated, and a self-motivator. The candidate must be willing to take on additional projects and work overtime when necessary.

Minimum Training Requirements

The list below includes the general training subjects, and not necessarily the exact name of the training course obtained:
  • Applicable Standard Operating Procedures
  • Good Clinical Practices (GCP Regulations' ICH Guidelines; Good Quality Practices)
  • 21 CFR Par 11 and Computer Security (Part 11, Electronic Records; Electron Signature-Scope and Applications; 21 CFR 11 and Industry Guidance's; Computerized Systems Used in Clinical Trials)
  • Good Clinical Data Management Practices
  • HIPPA
  • Drug Development and Approval Process
  • Data Management Overview
  • MedDRA and WHODRUG Overview
  • Sponsor/Study specific trainings, when applicable
  • Applicable system training

What's in it for you? Advanced Group offers competitive compensation, comprehensive benefits packages, and a flexible work environment designed to help our team members and their families stay healthy, meet their financial goals, and generally thrive in and beyond work. Visit the links below to discover all that Advanced Group has to offer:

Our Culture: https://careers.advancedgroup.com/embrace-our-culture

Career Development Opportunities: https://careers.advancedgroup.com/realize-your-potential

Community Programs: https://careers.advancedgroup.com/unleash-your-passion

It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

Advanced Clinical is a global clinical research services organization, providing CRO, FSP, Strategic Resourcing and Consulting Services for biopharmaceutical and medical device organizations. Our company is committed to improving all lives touched by clinical research and we address the hopes of patients and healthcare professionals with industry-leading services and technology in life sciences.  Visit our website to learn more about how we deliver a Better Clinical Experience: http://www.advancedclinical.com

Contact Us
  • United Kingdom
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert