Remote Clinical Data Manager

Placements24; Mansfield Woodhouse; Hybrid; GBP 45.000 - 65.000; Vollzeit

Benefits dieser Stelle

Health insurance

Dental insurance

Vision insurance

Retirement plan

Training programs

Remote work

Zusammenfassung

Placements24 is recruiting a Remote Clinical Data Manager to oversee data from study initiation to database lock, working entirely remotely from the UK. The role requires a strong understanding of clinical trial processes, data management systems, and regulatory compliance under GCP and ICH guidelines.

You will design CRFs/eCRFs, manage data entry and cleaning, and collaborate with biostatistics, programming, and clinical operations teams to ensure data integrity and timely trial milestones.

Qualifikationen

• Bachelor's degree in a scientific or healthcare-related field is required.
• Minimum of 4 years of experience in clinical data management.
• Proficiency with clinical data management systems (e.g., Medidata Rave, Inform, eClinical systems).
• Strong understanding of CDISC standards (SDTM, ADaM) and GCP/ICH guidelines.

Aufgaben

• Develop and manage DMPs for clinical trials.
• Oversee design and implementation of CRFs and eCRFs.
• Manage data entry, validation, and cleaning to ensure accuracy.
• Perform data review and query resolution with sites and study teams.
• Coordinate with biostatistics, programming, and clinical operations teams.
• Ensure compliance with GCP, ICH, and data privacy regulations.
• Oversee database lock activities and final sign-off.
• Contribute to development of DMPs, SOPs, and training materials.
• Act as primary contact for data management of assigned trials.

Kenntnisse

Clinical data management

CDISC SDTM/ADaM

GCP/ICH knowledge

Data validation

Remote collaboration

Ausbildung

Bachelor's degree in a scientific or healthcare-related field

Tools

Medidata Rave

Inform

eClinical systems

Jobbeschreibung

About the Role

Our client, a prominent contract research organization (CRO) deeply involved in pharmaceutical research, is seeking a highly competent and meticulous Remote Clinical Data Manager . This role is essential for ensuring the accuracy, integrity, and completeness of clinical trial data. You will be responsible for managing clinical data from study initiation through database lock, working entirely remotely. The ideal candidate will possess a strong understanding of clinical trial processes, data management systems, and regulatory requirements (GCP, ICH). This is a significant opportunity to contribute to critical clinical research projects from a remote location, playing a key role in the successful development of new therapies.

Key Responsibilities

• Develop and manage clinical data management plans (DMPs) for clinical trials.
• Oversee the design and implementation of Case Report Forms (CRFs) and electronic CRFs (eCRFs).
• Manage data entry, validation, and cleaning processes to ensure data accuracy and integrity.
• Perform data review and query resolution with clinical sites and study teams.
• Coordinate with biostatistics, programming, and clinical operations teams.
• Ensure compliance with GCP, ICH guidelines, and relevant data privacy regulations.
• Oversee database lock activities and contribute to final database sign-off.
• Contribute to the development and maintenance of data management SOPs and training materials.
• Act as a primary point of contact for data management aspects of assigned clinical trials.

Requirements

• Bachelor's degree in a scientific or healthcare-related field; Computer Science or Statistics background is a plus.
• Minimum of 4 years of experience in clinical data management within the pharmaceutical or CRO industry.
• Proficiency with clinical data management systems (e.g., Medidata Rave, Inform, eClinical systems).
• Strong understanding of clinical trial lifecycle, CDISC standards (SDTM, ADaM), and data validation principles.
• Knowledge of GCP and ICH guidelines related to clinical data.
• Excellent analytical, problem-solving, and organizational skills.
• Strong written and verbal communication skills, crucial for effective remote collaboration.
• Ability to work independently, manage multiple tasks, and meet project timelines.
• Experience with database design and programming is advantageous.

Benefits

This fully remote position offers a competitive salary and a comprehensive benefits package, including health, dental, and vision insurance, as well as a retirement savings plan. Our client is dedicated to fostering professional growth through access to training programs, online learning resources, and opportunities to work on diverse and challenging clinical trials. The flexibility of remote work contributes to an excellent work-life balance. Join a reputable CRO and play a vital role in advancing medical research from the comfort of your home.