Lead Clinical Data Manager

1 week ago

Melbourne, Victoria, Australia I-Pharm Consulting Full time

Lead Clinical Data Manager - Remote Australia

About the Company

Our client is a rapidly growing clinical research organisation dedicated to advancing medical knowledge and improving patient outcomes. Specialising in CDM, they work closely with pharmaceutical / Biotech and Clinical Research Organisations and provide tailored solutions.

Role Overview & Responsibilities

They are seeking a Lead Clinical Data Manager to join the team based remote anywhere in Australia. In this role, you will be responsible for overseeing the data management activities for multiple clinical trials, ensuring data integrity, quality, and compliance with regulatory requirements.

  • Lead and mentor a team of Clinical Data Managers, providing guidance, training, and support to ensure consistent and efficient data management practices.
  • Develop and implement data management plans, including data collection, validation, coding, and reporting strategies.
  • Collaborate with cross-functional teams, including clinical operations, biostatistics, and medical writing, to ensure seamless integration of data management activities.
  • Conduct data review meetings and oversee data cleaning and query resolution processes.
  • Ensure adherence to Good Clinical Data Management Practices (GCDMP), ICH-GCP guidelines, and applicable regulatory requirements.
  • Participate in the development and maintenance of standard operating procedures (SOPs) and data management tools.
  • Contribute to the selection, implementation, and validation of clinical data management systems and electronic data capture (EDC) platforms.
  • Represent the data management team in internal and external meetings, presenting data metrics and reports as required.
  • Participate in the preparation of clinical study reports and regulatory submissions.

Qualifications and Experience

  • Bachelor's degree in a relevant field (e.g., Life Sciences, Biostatistics, Computer Science) or equivalent experience.
  • Minimum of 5 years of experience in clinical data management, with at least 2 years in a lead or supervisory role.
  • Comprehensive knowledge of Good Clinical Data Management Practices (GCDMP), ICH-GCP guidelines, and regulatory requirements.
  • Proficiency in clinical data management systems, EDC platforms, and data analysis tools.
  • Strong analytical and problem-solving skills, with the ability to identify and resolve data issues.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
  • Proven leadership and mentoring abilities, with the capacity to motivate and develop team members.
  • Attention to detail and a commitment to maintaining high standards of data quality and integrity.

Apply direct now with your CV (no need to write a cover letter), or contact Keeley Munday on / -

Note: due to high level of applicants, only those successful will be contacted.

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