MLG Consult, a leading consulting firm specializing in the life science industry, is seeking a meticulous and detail-oriented Clinical Data Manager to join our team. At MLG Consult, we prioritize a healthy working environment and employee well-being, offering a supportive and collaborative culture.

Responsibilities:

1. Develop and implement data management plans for clinical trials, ensuring compliance with regulatory requirements and industry best practices.
2. Oversee data collection, validation, and cleaning processes to ensure accuracy, completeness, and integrity of clinical trial data.
3. Collaborate with cross-functional teams to establish data standards, data collection tools, and database specifications.
4. Design and maintain clinical databases, including the development of electronic case report forms (eCRFs) and data validation checks.
5. Perform data quality reviews and resolve any data discrepancies or anomalies through collaboration with study sites and data vendors.
6. Ensure timely and accurate data entry and database lock according to study timelines and project requirements.
7. Generate and distribute data management reports, including data listings, query reports, and data reconciliation reports.
8. Participate in the development and implementation of data management standard operating procedures (SOPs) and work instructions.
9. Coordinate and manage data transfers between internal and external stakeholders, including clinical research organizations (CROs) and data vendors.
10. Stay updated with relevant regulatory guidelines and industry trends related to clinical data management, implementing necessary changes to maintain compliance.

Qualifications:

1. Bachelor's or Master's degree in a relevant field, such as Clinical Data Management, Biostatistics, or a life science discipline.
2. Proven experience in clinical data management, preferably in a CRO, pharmaceutical company, or clinical research setting.
3. In-depth knowledge of clinical data management practices, industry standards (e.g., CDISC), and regulatory requirements (e.g., FDA, ICH-GCP).
4. Proficiency in using clinical data management systems and electronic data capture (EDC) platforms.
5. Familiarity with clinical trial protocols, clinical data standards, and medical coding systems (e.g., MedDRA, WHODrug).
6. Strong attention to detail and excellent analytical skills, with the ability to identify data discrepancies and implement data cleaning processes.
7. Proficient in data review, query management, and resolving data discrepancies with study sites and data vendors.
8. Effective communication and collaboration skills to work with cross-functional teams and external stakeholders.
9. Ability to work independently, prioritize tasks, and meet project deadlines in a fast-paced and dynamic environment.
10. Demonstrated commitment to a healthy work environment and a focus on employee well-being and work-life balance.

Join MLG Consult, where we value a healthy working environment and employee lifestyle. Enjoy competitive compensation, professional growth opportunities, and contribute to our mission of delivering exceptional services to clients. Apply now for the Clinical Data Manager position at MLG Consult.