Please follow application instructions found at end of posting.
We are seeking a Clinical Data Manager. The successful candidate will possess the following skills: strong technical background, attention to detail, ability to multi-task, and excellent interpersonal communication. Must be eligible to work in the US without company sponsorship. Please see summary below.
The Clinical Data Manager is responsible for the Clinical Data Management team role which ensures data collection and processing that meets standards of data quality, validity, and security. CDM responsibilities include clinical database/CRF design, data collection, and processing for final database preparation activities associated with clinical trials for submission to regulatory agencies throughout the world. Perform clinical study team member CDM role in working collaboratively with biostatistics, clinical, safety, and regulatory groups within the company, and with CROs, and globally as needed.
Roles and Responsibilities
- Conduct all CDM role responsibilities in support of clinical study teams and as defined in policies and procedures.
- Collaborates with Clinical Study Team to create protocol case report forms (CRF).
- Designs Electronic Data Capture (EDC) databases to collect and process CRF data. May include coordination with EDC vendors and programmers to deliver a validated system.
- Perform User Acceptance Testing (UAT) of the EDC database.
- Develops a Data Management Plan (DMP) to define the data collection and processing workflow.
- Conduct data processing and review in accordance with the study protocol, DMP, and EDC system instructions.
- Generate standard and ad hoc reports of EDC CRF or metric data for study team and management reporting.
- Coordinates the development of Case Report Forms or EDC forms with clinical and biostatistics groups.
- Provides data management expertise on clinical study teams and train clinical personnel n CRF and EDC as needed.
- Perform database lock activities to ensure the accuracy and completeness of final clinical trials databases prior to submission to Biostatistics for analyses and submission to the FDA and other regulatory agencies in other countries.
- Participate as a clinical study team member and contribute to team deliverables to include protocol design, site EDC training, and study conduct activities through completion of the study report. May include performance of Quality Control checks for study documents and data output.
- Participate in departmental developmental initiatives (e.g. training, SOP development, etc.).
- BS in science or related technical field
- Experience with medical device trials
- At least 3 years of clinical data management experience in a pharmaceutical, medical device or CRO environment.
- Familiarity with and knowledge of personal computers and database management software, MS word, and MS excel.
- Prior use of commercially available EDC systems required; experience with Clindex or Medidata RAVE desired.
- Data analysis and data entry experience
- Problem-solving / trouble-shooting experience
- Effective communication and organizational skills.
Compensation and Benefits
We offer a competitive compensation package to full-time hires. Our benefit package is comprehensive and includes medical insurance, life insurance, disability insurance, dental and vision insurance, flexible medical and childcare spending accounts, 401k, paid holidays and paid vacation, casual dress, creative workplace. Drug screen and background check required.
Must be eligible to work in the US without company sponsorship.
Preferred: go to www.atricure.com/Join_the_Team/Open_Positions. Please have your resume and a cover letter available for upload as a Word document. May also fax resume and a cover letter to 513-644-4751. Must have CLIN DATA MGR on the cover sheet. NO PHONE CALLS PLEASE