Grifols Shared Services North America, Inc Sr Clinical Data Manager in San Diego, California
Grifols is a global healthcare company whose mission is to improve the health and well being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
The Senior Clinical Data Manager provides technical and operational expertise to the project teams and ensures the data collected meets the requirements of the study objectives for the purpose of clinical study reports, publications, and regulatory submissions. This position leads and coordinates functions for multiple assigned projects related to the planning, execution, collection, and cleaning of clinical data. This position complies with the company’s SOPs, guidelines and standards ensuring data integrity is maintained at all times.
Primary Responsibilities for Role:
Serves as a data management expert and is the CDM lead for assigned clinical studies on multidisciplinary project teams.
Develops and manages timelines for key clinical data management deliverables in coordination with the clinical data management CRO and Grifols project team.
Participates in the evaluation and selection of clinical development vendors, e.g. Contract Research Organizations (CROs) and labs.
Participates in the contract process and invoice approval for selected vendors.
Monitors vendor performance to ensure timelines and data quality standards are met.
Reviews and approves key clinical data management deliverables, including: Case Report Form (CRF) design, CRF completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specifications, and electronic data transfer agreements.
Oversees all clinical data management activities, database cleaning and lock activities including developing data management plans, supervising database development and reviewing and processing clinical trial data to ensure completeness, accuracy and consistency of clinical trials databases.
Evaluates and implements new technologies to enhance data management processes.
Develops or updates clinical data management working practices and Standard Operating Procedures (SOPs).
Ensures compliance of clinical data management processes with applicable regulations and guidelines.
Supervises and provides leadership, mentoring and training to Clinical Data Management staff assigned to work on their projects.
Leads interactions between company and outside vendors on the collection, transmittal and transfer of study specific instrument and laboratory data.
Works with biostatisticians and SAS programmers to harmonize data collection, compile and maintain SAS data standards.
Provides review and oversight on quality database design, validation, and deployment to ensure quality and efficiencies through data and process standardization.
Reviews clinical study protocols and statistical analysis plans and ensure data quality for data analyses.
Serves as a technical resource for data management related activities; troubleshoot technical problems.
Knowledge, Skills, and Abilities:
Excellent verbal and written communication skills and strong interpersonal skills.
Experience with project management.
Experience managing vendors and data management activities from project initiation through to database closeout is required.
Comprehensive experience working with clinical database systems and electronic data capture (EDC) is required.
Experience with CDISC CDASH and SDTM standards.
Able to effectively manage multiple projects and adapt flexibly to changing priorities.
Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors.
Strong analytical and problem solving skills.
Experience working under Good Clinical Practices and other Federal Drug Act guidelines.
SAS programming experience a plus.
Experience with DataTrak a plus.
Bachelor's degree with an accredited institution.
8 plus years of experience in clinical data management or equivalent experience.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
Learn more about Grifols at http://www.grifols.com/es/web/international/home