Senior Manager, Clinical Data Management - Permanent - Remote
Proclinical Staffing is seeking a Senior Manager, Clinical Data Management to join a cutting-edge biotech company. This is a permanent role with the opportunity to work remotely.
Primary Responsibilities
As the Senior Manager, Clinical Data Management, you will play a crucial role in maintaining the integrity and quality of data management outputs across clinical studies. This position involves leading and overseeing all aspects of data management, from planning and coordination to execution and quality control. The successful candidate will be responsible for managing relationships with external partners, ensuring compliance with Good Clinical Practices (GCPs), regulatory guidelines, standard operating procedures (SOPs), and other relevant standards.
Skills & Requirements:
- A background in natural/life sciences or a related scientific field
- At least 7 years of experience in Clinical Data Management, including direct experience in overseeing DM activities and leading projects
- Comprehensive understanding of ICH-GCP and familiarity with various Clinical Database Systems and processes.
- Proficiency in using at least one major Clinical Data Management System (e.g., Medidata, OCRDC, Inform, etc.).
- This role is ideal for a dynamic and experienced data management professional seeking to contribute to high-quality clinical research projects by leveraging their expertise in data management, regulatory compliance, and project management.
The Senior Manager, Clinical Data Management will:
- Act as the principal liaison for all data management-related communications with external partners & CRO's.
- Provide specialized data management and technical guidance throughout the lifecycle of clinical data management activities, collaborating closely with data managers and key stakeholders.
- Ensure the execution of clinical data management tasks aligns with overall strategy and adheres to established standards.
- Negotiate directly with CROs regarding timelines, processes, and quality concerns.
- Approve all data management documentation, including CRF, data validation plans, and others, ensuring compliance with DMP and quality standards.
- Conduct periodic reviews of clinical data and perform quality checks to maintain data integrity.
Compensation:
$150,000 - $170,000 annually
If you are having difficulty in applying or if you have any questions, please contact Jennifer Iantosca at (+1) 215-660-3706 or j.iantosca@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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