Clinical Data Manager

Peachtree BioResearch Solutions, a Julius Clinical Company, is a global specialized full-service CRO providing highly specialized study operations teams for pharmaceutical, biotech, and medical device companies.  Formed over 15 years ago by a pharma leadership team experienced in buying CRO services with the purpose of creating trusting partnerships with sponsor clients - no matter their budget. We do this by investing in people who thrive in an environment where their experience and contributions can be felt throughout the organization.  It's an exciting time as we expand our global reach, while still offering a personalized approach to sponsors and delivering incredible value. 

The data management group at Peachtree has been the backbone of the company since its inception. We are looking to add an experienced Clinical Data Manager (CDM)  to a very high-performing team.    The CDM is responsible for all data management activities associated with the acquisition, documentation, review, cleaning and processing of clinical data in clinical trials. 

RESPONSIBILITIES

• As a member of the clinical study team, relay information regarding data management status, knowledge regarding area of discipline, and timelines affecting Data Management deliverables.
• Ensuring the Case Report Form is designed according to the Clinical Protocol, utilizing Data Standards where possible, and document deviations, if necessary.
• Creating the Data Management Plan, Data Cleaning Plan, Quality Control Plan, and Data Management Report while ensuring consistency with the Clinical Trial Protocol and are in compliance with internal or sponsor procedures, international or national regulations and Good Clinical Practices.
• Projecting, planning, developing, implementing and delivering quality results in a timely manner. This will require the use of facts, data, measurements and a systematic approach and is accomplished specifically by:
• Interpreting the Clinical Protocol to ensure the accurate and efficient design of the CRF                             
• Analyzing metrics surrounding the activities associated with the acquisition, documentation, review, cleaning and processing of clinical data
• Interpreting study timelines and prioritizing workload appropriately.
• Assisting with Clinical Data Associate activities during times of peak workload.

EXPERIENCE:

• Clinical Data Management experience in a CRO
• Working knowledge of medical terminology, federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices
• Excellent communication, organization, and problem solving skills
• Ability to work independently, as well as handle a number of diverse projects simultaneously, under tight time constraints
• Ability to engage and demonstrate cooperative behavior to support team efforts
• Experience in responding rapidly to changing priorities and in managing aggressive deadlines.

In addition to working with great people on high performing teams, full-time employees receive:

• Medical, Dental, Vision, Life, Disability coverage
• 20 days PTO + PTO rollover + 13 paid holidays
• 401(k)