Manager for Clinical Data Management Operations - Permanent - California
Proclinical is actively seeking a Clinical Date Management operations Expert for a permanent position. This is an on-site role based in Pasadena or San Diego, California.
Primary Responsibilities:
This role is pivotal in planning, coordinating and ensuring the delivery of high-quality, reliable clinical trial data. The successful candidate will be the go-to person for all data management activities across multiple clinical development programs. This is a fantastic opportunity for someone who thrives in a fast-paced environment and is passionate about quality and data-driven evaluation.
Skills & Requirements:
- Bachelor's degree in life science or a similar field.
- Strong commitment to quality programs and data-driven evaluation.
- Excellent interpersonal, written and verbal communication skills.
- Ability to convey technical information to a non-technical audience.
- Working knowledge of GCP standards, CDISC standards, FDA and ICH guidelines as well as recommended CDM best practices.
- Excellent understanding of the clinical trial database lifecycle.
- Knowledge of CDISC standards, specifically SDTM datasets/SDTM mapping.
- Thorough understanding of the drug development process from IND to NDA.
- Good knowledge of database and dictionary structures.
- Established experience with EDC vendors and processes.
The Manager for Clinical Data Management Operations' responsibilities will be:
- Act as the go-to expert for Clinical Data Management (CDM) Operations.
- Lead data management activities for multiple clinical development programs.
- Manage interfaces with CROs, clinical sites, and laboratories.
- Participate in reviewing study documents such as clinical study protocols and statistical analysis plans.
- Oversee the identification, evaluation, and validation of CDM documents and databases.
- Generate data listings and other data review tools for reporting study metrics.
- Support clinical study report creation by contributing to the data quality assurance section.
- Ensure CDM compliance with protocols, SOPs, and overall clinical objectives.
- Lead or contribute to the development and implementation of departmental policies, standards, and process improvement initiatives.
Compensation:
- $110,000 - $150,000 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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