Sampson Medical Search

             Phone  310-305-8468                   sms_resume@earthlink.net

               Please send a resume in a word attachment directly to                            

            sms_resume@earthlink.net      Thank You!!!        Judie Sampson

Our Client Company is seeking a Director of Data Management.  This position will require Strategic, operational and administrative oversight of the Clinical Data Management Program.  Additional key responsibilities include system owner of clinical data management system, coordination of clinical data input from several sources, liaison with Clinical Operations and the strategic leadership of process and technical improvement initiatives.

Essential Functions

·          Provide leadership & expertise with focus on design and planning of the clinical data management  program

·          Study design with focus on innovation to solve key development program strategic issues

·          Overseeing clinical trial databases including database design and maintenance, managing electronic data transfers, study randomization coordination and programming of data rules, checks, listings, and reports

·          Collaborates and coordinates with others to design and implement clinical protocols and data collections systems

·          Develops systems for organizing data to analyze, identify and report data trends

·          Overseeing data management issues by reviewing protocols for cross-project consistency, and identifying standard Case Report Form modules to meet objectives and develops data quality plans.

·          Statistical analysis & interpretation, new methodology development & report writing, presentations & publications, regulatory strategy & interactions.

·          Directing and managing work of clinical data team, data statisticians & outside vendors. 

·          Ensure compliance w process & quality of deliverables within the clinical data management program.

Education / Experience

·          PhD in a scientific discipline or equivalent with 10+ yrs of working in a CDM department within a pharmaceutical, biotech or CRO   Previous management experience 5+ yrs is required

Skills

·          Knowledge of experimental design, multivariate analysis, regression analysis, and sampling techniques

·          Experience with CDM activities during study start up, maintenance and closeout

·          Working knowledge of EDC applications

·          Proficient knowledge of drug development processes and phases of clinical trials

·        Clear written and verbal communication skills

·        Knowledge of Microsoft office

Our client is a small Biotech Company located in the Midwest with a wonderful group of people

in a fantastic city that is a great place for raising a family.