Clinical Data Manager Job at cGxPServe, Lake County, IL

TjYwaTRUbWpoeGFrQzZaWlpCcDFNZDVIa3c9PQ==
  • cGxPServe
  • Lake County, IL

Job Description

Job Description:
The Data Manager, Data Management Oncology Early Development (OED) is a member of the Data Management and Analysis team responsible for supporting the successful delivery of data and processes conducted by CROs. This individual will collaborate closely with the Data Management & Analysis team within OED and internal colleagues to ensure data integrity and quality for oncology first in human clinical trials up through clinical proof of concept.

Responsibilities:
  • Provide CRO oversight and feedback related to the data management operations, issues and trends in performance.
  • Completes assignments as delegated by OED Data Management relating to operational objectives and study deliverables.
  • Effectively utilizes available technology, EDC platforms, Reporting and Visualization tools.
  • Reviews CRO deliverable to ensure adherence to data standards and protocol requirements implemented within the design.
  • Reviews study execution documents including specifications, data management plan, data review plan, data transfer plan and other cross functional plans delineating data review needs.
  • Provide CRO oversight of data management tasks in adherence with established standards including third party vendor data reconciliation, medical coding processing, protocol deviation collection, and query management to identify errors and inconsistencies in clinical data and ensure their resolution.
  • Identify and triage issues as they occur.
  • Ensures CRO data management adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, and to data management quality standards.
Requirements:
  • Bachelor's degree in business, management information systems, computer science, life sciences or equivalent.
  • Must have at least 4+ years of pharmaceutical, clinical research, data management, health care or other relevant experience.
  • Strong understanding of clinical trial processes and clinical technology.
  • Demonstrated history of successful execution in a fast-paced environment and in managing multiple priorities effectively.
  • Strong understanding of GCDMP.
  • Demonstrated effective communication skills.
  • Demonstrated effective problem-solving skills.
Top Skills:
  • Must have at least 4+ years of pharmaceutical, clinical research, data management, health care or other relevant experience.
  • Strong understanding of clinical trial processes and clinical technology.
  • Demonstrated history of successful execution in a fast-paced environment and in managing multiple priorities effectively.
  • Strong understanding of GCDMP.
  • Demonstrated effective communication skills.
  • Demonstrated effective problem-solving skills.

Job Tags

Local area,

Similar Jobs

Weatherby Healthcare

Locum Tenens Physician Assistant - Cardiology - $80-100 per hour Job at Weatherby Healthcare

 ...Weatherby Healthcare is seeking a Physician Assistant Cardiology for a locum tenens job in Christiansburg, Virginia. Job Description & Requirements Specialty: Cardiology Discipline: Physician Assistant Duration: 13 weeks Employment Type: Locum Tenens... 

Magi K

All languages - English Over the phone Interpreter Job at Magi K

We are hiring ALL LANGUAGES-ENGLISH OVER-THE-PHONE INTERPRETERS&##128170; We are an equal opportunity employer!&##128204;Freelance Contract Your role Your job as an Over-the-Phone interpreter involves providing clear and accurate interpretation between languages...

Market America Inc

Shopify Platform Developer Expert Job at Market America Inc

 ..., a product brokerage and Internet marketing company that specializes in One-to-One Marketing, is seeking an experienced Shopify Platform Developer Expertfor our IT team. This role will lead the development, customization, and integration of our Shopify store(s)... 

Inspire Psychiatric

Psychiatric Mental Health Nurse Practitioner Job at Inspire Psychiatric

 ...Join Our Team: Psychiatric Nurse Practitioner at Inspire Psychiatric Inspire Psychiatric is growing, and we're looking for a Psychiatric...  ...practice. This is a chance to provide compassionate, top-tier mental health care in a collaborative setting. You'll work closely... 

AppleOne

IT DIRECTOR Job at AppleOne

 ...IT Director oversees planning, implementation, security, and operation of an organizations technology infrastructure and information systems to support efficiency, innovation, and quality public service. Key responsibilities Develop and execute long-term IT strategies...