Data Manager Consultant

🔥 14 hours ago

🇪🇺 Europe – Remote

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

📊 Data Scientist

👻 Ghost score 10%

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ClinChoice

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ClinChoice is a global full-service contract research organization (CRO) established in 1995, specializing in clinical development, post-marketing, and functional service support for the pharmaceutical, biotechnology, and medical devices industries. They provide comprehensive solutions from early clinical development to post-approval lifecycle management, with expertise in a variety of therapeutic areas such as autoimmune and inflammation, dermatology, endocrinology, infectious diseases, neuroscience, and oncology. ClinChoice aims to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. The company supports its clients with clinical, regulatory, and operational expertise across all phases of product development.

📋 Description

• Lead data management activities for clinical trials, including database setup, study conduct, and close-out • Ensure study deliverables meet timelines and quality standards • Collaborate with cross-functional teams to maintain project timelines and deliver high-quality data management deliverables • Review clinical research documents, including protocols and Case Report Forms • Create and review electronic Case Report Form specifications • Develop Data Management Plans, Data Validation Plans, eCRF Completion Guidelines, Data Entry Guidelines, and Data Review Plans • Develop edit rules/checks, query logic, and query messages • Develop User Acceptance Testing Plans and test data entry screens and edit checks • Create and provide training to clinical teams and sites • Perform ongoing data review and reconciliation activities and provide metrics and patient trackers • Perform database lock/unlock and freeze/unfreeze activities for statistical review, interim analysis, and final database lock • Coordinate archiving of study databases and related documents • Create Data Transfer Specifications and perform external vendor reconciliation • Perform SAE reconciliation • Maintain and improve client satisfaction through high-quality service, communication, and clinical data management

🎯 Requirements

• Bachelor’s degree in clinical, pharmacy, biological, mathematical sciences, a related field, or a nursing degree • At least 3 years of data management and/or related work experience in the pharmaceutical industry • Working knowledge of clinical research, clinical trial processes, related regulatory requirements, and terminology • Strong knowledge and experience with several electronic data capture systems, such as Medidata Rave, Oracle InForm, OpenClinica, and Medrio • Perform duties in compliance with SOPs, GCP, and ICH guidelines • Ability to prioritize and adapt quickly in fast-paced and changing industry conditions • Ability to lead a study or data management team independently • Ability to drive quality and efficiency to meet timelines and milestones and deliver high-quality data management deliverables • Excellent verbal and written communication skills • Proficient in Microsoft Office, including Outlook, Word, Excel, and PowerPoint

🏖️ Benefits

• Professional development and continuous training • Work-life balance • Collaborative “one-team” culture • Equal opportunity and diversity/inclusivity • Career development opportunities • Phone interview as the first step of the application process