Senior Clinical Data Coordinator

Location
Timisoara, RO;Homeworking
Salary
Competitive
Posted
28 Apr 2021
Closes
28 May 2021
Ref
2020-12334
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Overview

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.

Senior Clinical Data Coordinator - PRIMARY FOCUS is on data review and to support the CDMs

The Senior Clinical Data Coordinator is responsible for performing activities related to clinical database development, data review and maintenance of specific data management documentation pertaining to the conduct of Phase I - III clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines to ensure that a quality work product is produced and timelines and deliverables are met.

Responsibilities

  • Perform User Acceptance Testing (UAT) of clinical databases.
  • Perform Quality Control (QC) of clinical databases.
  • Perform ongoing data review, including reconciliation of third party data streams and serious adverse event reconciliation with the safety database.
  • Perform ongoing updates of Data Management-related documentation, as needed.

Qualifications

  • A minimum of 2+ years of data coordinator experience is required.
  • A Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RT) is preferred, but individuals with commensurate experience will be considered.
  • Experience with Electronic Data Capture (EDC) system(s) is required.
  • Experience with Oracle Inc.'s Inform™ EDC system is preferred.
  • Oncology and/or inflammatory therapeutic area experience is preferred.
At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Group in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity

It is Advanced Group's practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or 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 meet to discuss the appropriate alternatives available.

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