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CLINICAL SERVICES GROUP

MDCI has a number of open positions in our Clinical Services Group, which supports clients through all phases of clinical development and testing, for both new and currently marketed medical devices. At any one time we are involved in the design, management, and monitoring of an average of 20 to 30 medical devices studies, representing varied technologies and therapeutic areas.

SENIOR BIOSTATISTICIAN

This position reports to the Vice President of Clinical Services, with the following principal responsibilities:

• Oversee design and analysis of clinical trials for medical devices and in vitro diagnostic products
• Consult with clients on appropriate study endpoints
• Collaborate with sponsors and medical consultants to prepare statistical sections of protocols and analysis plans
• Work with project team members in the preparation of all clinical study reports to the sponsor and regulatory bodies
• Supervise data management in the department

Qualified candidates will have a Ph.D. in biostatistics with experience in a clinical trial setting. The ideal candidate will have an intense interest in functioning as a consulting statistician in support of clinical studies of medical devices, will have outstanding communication skills, and will enjoy working as part of a team.

PRINCIPAL SAS PROGRAMMER

This position reports to the Vice President of Clinical Services, with the following principal responsibilities:

• Primary responsibility for all SAS programming in the department
• Develop SAS programs to support submissions to regulatory bodies
• Write and update appropriate SOPs for documentation, programming, and archiving to ensure compliance with MDCI's quality system
• Collaborate with project manager and project team to produce all required reports for client and regulatory bodies

Qualified candidates will have a minimum B.S. or B.A. with concentration in mathematics, computer science, and/or statistics, a minimum of 5 years experience as a SAS programmer, and a proven record of advancement as a SAS programmer in an appropriate clinical trial setting.

CLINICAL DATA MANAGER

Responsibilities include the design, development, and maintenance of study databases; tracking of study status; managing the quality control of data; writing queries and integrating query responses; and periodic reporting of clinical trial data using standard software.

Qualified candidates will have a minimum B.S. with 1 to 2 years experience as a data manager working with pre-clinical or clinical trial data. EDC experience and Crystal Reports proficiency is a plus.

SENIOR CLINICAL RESEARCH ASSOCIATE

The Senior Clinical Research Associate is responsible for assisting in the review of all aspects of clinical field trials conducted to determine performance of medical devices in a controlled medical environment, with the following principle responsibilities:

• Conduct on-site pre-investigational site visits, monitor medical device clinical trials, manage study progress, and other required management reports as specified by the clinical trials manager; conduct study closeout visits and pre-FDA inspection site visits
• Collaborate with clinical trials staff in protocol development case report form design, study handbook development, and FDA clinical reports
• Assist with training and supervision of other CRA staff and act as lead CRA as required.
• Travel 50% to 60% of the time.

Qualified candidates will have a minimum B.S. or advanced degree in health science or nursing, with at least 5 years of monitoring experience as a CRA, and a minimum of one year experience in the area of cardiac medical devices. Knowledge of appropriate FDA regulations and guidelines and GCPs, excellent verbal and written skills, and superior communication skills for site/sponsor contact are required. Qualified candidates will have previous experience training and/or mentoring CRAs and acting as a lead CRA. Must have a thorough knowledge of MS Word, Excel, PowerPoint, and Outlook. Certification as CRA by ACRP, SoCRA, or other professional organization preferred.

CLINICAL RESEARCH ASSOCIATES

(East Coast, Midwest, South, Texas)

Responsibilities include monitoring and auditing of clinical data for medical device studies, including requiring frequent interaction with physicians and/or health care professionals. 60% to 70% travel required.

Minimum qualifications include B.S. in science field, nursing, or related education. Qualified candidates will have a minimum of 2 years of current monitoring experience, along with excellent verbal and written communication skills and experience with MS Word, Excel, and Outlook.

Contract Clinical Monitor

MDCI is seeking a french-speaking clinical research associate (CRA)located in Ontario or Quebec, Canada or in the New England area for part-time study monitoring. The candidate must have five years of clinical monitoring experience. Medical device study experience is preferred.