Jobs

Wimmer Clinical Consulting Services is a privately owned Contract Research Organization (CRO) located in Liberty, Missouri.​  We provide expertise in clinical trial management, computer systems development, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in pharmaceutical development.​ We are seeking qualified applicants for the positions listed below. Applicants may email their cv to derek@wimmerclinical.com

Clinical Data Manager

Responsibilities:

• Work in a team environment to design, develop, and manage clinical trial data systems, supporting materials, and processes utilizing strong data management and computing skills.​

• Provide support to clinical site staff regarding queries of EDC systems, develop site training materials and conduct training sessions on use of EDC systems.​

• Develop, generate and manage data queries, reports, and other data related activities.​

• Perform Data Listings Reviews.
  

• Contribute to the quality and accuracy of various types of clinical study reports for the duration of the trial.​ 

• Duties may include but are not limited to; medical writing, as well as planning and implementing QC steps, such as checking tables, figures, and listings, verifying data entry, reviewing SAS output, and reconciling text and tables.​ 

Required Skills:

• Bachelor's degree, preferably in a health-related or scientific discipline.​

• 1-3 years oncology clinical trials experience preferred.​

• Knowledge of FDA guidelines regulations and Good Clinical Practice.

• Familiar with the drug development process and pharmaceutical industry standards and practices.

• Excellent organizational skills with ability to work in a high volume and strict deadline environment.

• Strong computer skills.​ Experience with database design and architecture is desirable, including OpenClinica and MedNet Solutions.
  

• Previous experience with CRF design, EDC systems, CTMS, or other web-based data collection systems.​

• Change management, requirements documentation, and attention to detail a must.​

Responsibilities:

• Functions as a liaison with Investigator sites to assist with site recruitment, collection of regulatory documents, and general study support.

• Maintains and supports data tracking systems for clinical study documents

• Assists with the collection, review, and tracking of regulatory documents and IRB materials

• Produces Investigator Manuals, CRA Training Manuals, Investigator Meeting materials

• Assists in the development of project documents, including status reports, using word processing, spreadsheet, presentation, and database software.

• Prepares materials for project and sponsor meetings

• Attends project and sponsor meetings and prepares agendas and minutes, as needed

• Compiles and prepares weekly/monthly and ad-hoc project reports, prepares mail merges and mass mailings for projects

• Tracks monitoring visit reports and related correspondence and expense reports

• Implements patient tracking systems, enters patient enrollment information, and compiles enrollment reports

• Prepares, maintains and archives project trial master files

• Participates in the site recruitment and selection process, including sending and tracking of evaluation materials

• Assists with the managing of Investigator and Client Meeting Logistics

• Complies with Good Clinical Practice and follows Standard Operating Procedures.

• Performs all other duties as assigned

Required Skills:

• Bachelor's degree, preferably in a health-related or scientific discipline.​

• 1-3 years oncology clinical trials experience preferred.​

• Knowledge of FDA guidelines regulations and Good Clinical Practice.

• Familiar with the drug development process and pharmaceutical industry standards and practices.

• Excellent organizational skills with ability to work in a high volume and strict deadline environment.

• Strong computer skills.​ Experience with database design and architecture is desirable, including OpenClinica and MedNet Solutions.
  

• Previous experience with CRF design, EDC systems, CTMS, or other web-based data collection systems.​

• Change management, requirements documentation, and attention to detail a must.​