JOBS – May, 2015

Please see below opportunities and send resume as an attachment to wd_darshana at hotmail dot.  My imminent full time openings are for Senior RA/QA and Senior Electrical, Mechanical, Quality and Software Engineering – most of these require strong medical device experience.  More opportunities and details on all opportunities coming soon.  All US opportunities are for US based and local candidates.  When sending a resume, please mention job you are interested in, in the subject line and in the email include a brief summary of how best the job description matches your background and where the gaps are.  Also include details on your current compensation and compensation expectations.

Data Manager – San Diego, CA (contract opportunity)

* Database Development/Management
* Protocol review
* Develop or review database definition file to create CRFs
* Develop or review Edit Check Specifications
* Perform or oversee User Acceptance Testing (UAT) of the CRFs and Edit Checks for the database in development
* Manage change requests during the course of the trial after database is Live

Document/Documentation Development
* Write CRF Completion Instructions for in-house managed trials; review for outsourced trials
* Create the Data Management Plan (DMP) (hard copy and electronic) and update throughout the study for in-house managed studies; review/create for outsourced trials
* Write study-specific Manual Review Guidelines for in-house managed studies; review for outsourced trials
* Maintain Study Information Table
* Write and maintain Data Transfer Agreements with ancillary vendors

Data Management/Review
* Perform or oversee manual review of all CRFs generating queries as needed for in-house managed studies
* Ensure review and upload of all external data (e.g., labs and PK data)
* Medical coding for in-house trials; review for outsourced trials
* Track and resolve all queries for in-house trials; review for outsourced trials
* SAE reconciliation
* Produce and/or review data listings
* Provide Data Management summary reports to management and Clinical Operations
* Provide ad hoc reports from the database, as requested
* Ensure that database is closed and locked at the end of the trial

Administrative Duties
* Attend trial and project team meetings
* Serve as liaison between Data Management and other departments
* Manage Data Management timelines with outsourced vendors
* Other duties as assigned

* Bachelor’s Degree in a science related field preferred
* Minimum 3 years data management experience preferably experience in cardiovascular, metabolic, neurological indications in the rare disease space
* Excellent written and verbal communication skills
* Proficient in MS Office
* Experience with Electronic Data Capture; BioClinica Express preferred
* Knowledge of CDISC standards and implementation of CDASH/SDTM
* Outsourcing management experience
* An ability to be productive and successful in an intense work environment

More opportunities and more details on below opportunities will be posted by June, 1.

Director of Mechanical Engineering – San Jose, CA
Requires 20+ years experience in polymers, balloons manufacturing. Complete details will be posted soon.

Mechanical Engineer – San Jose, CA
Requires 5+ years medical device experience.  Details will be posted soon.

Quality Engineer – San Jose, CA
Requires BS in Engineering and 10+ years medical device QE experience.  Details coming soon.

Physiologist – San Jose, CA
Requires large animals survival surgery experience.  Details coming soon.

Biochemist – San Jose, CA
Requires PhD + 3-5 years industry experience.  Details will be posted soon.

Ruby on Rails VP level experience – San Mateo, CA

Senior Electrical Engineer – Austin/ San Antonio – TX

Senior RA/QA Leader – East Coast

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