Job Highlights
Not Disclosed
Remote Job
Mid-Senior level
Posted 1 year ago
Job details
Peachtree BioResearch Solutions is a specialized full-service CRO that "thinks like a sponsor". Formed almost 15 years ago by a leadership team experienced in buying CRO service while at a global pharma, our operational teams are highly experienced and bring valuable insight for our small sponsor clients - no matter their budget. We do this by investing in people who thrive in an environment where their experience and insight can be leveraged beyond their main functional area. This is a great environment for people who want to do more.
Summary:
Peachtree BioResearch Solutions is looking to add a Senior Clinical Data Associate to our team. This person will report to the Manager, Clinical Data Management. This a fully remote position open to candidates in the United States. The selected candidate will be responsible for leading the efforts to perform data cleaning activities, including data quality assurance checks on clinical data collected for investigational drugs in clinical trials, to ensure data is of high quality and ready for statistical analysis.
What You'll Do:
The Senior Clinical Data Associate (CDA) will have responsibilities that include, but are not limited to:
Summary:
Peachtree BioResearch Solutions is looking to add a Senior Clinical Data Associate to our team. This person will report to the Manager, Clinical Data Management. This a fully remote position open to candidates in the United States. The selected candidate will be responsible for leading the efforts to perform data cleaning activities, including data quality assurance checks on clinical data collected for investigational drugs in clinical trials, to ensure data is of high quality and ready for statistical analysis.
What You'll Do:
The Senior Clinical Data Associate (CDA) will have responsibilities that include, but are not limited to:
- Acting as a CDA leader in reviewing and interpreting automated data discrepancy output, as well as performing manual listing reviews and generating data queries to be sent to the investigational site, following standard conventions and procedures.
- Managing the data cleaning process for the study, including interpreting clinical site responses to queries, and determining whether the responses are sufficient.
- Proactively updating the clinical database with the resolution provided and determining the resolution status of the queries, for studies using paper-based processes.
- Leading the efforts in regular status updates to the Clinical Data Manager regarding data cleaning efforts to facilitate an expeditious database lock.
- Performing quality control measures to ensure the final clinical database is prepared for analysis and reporting as specified in the Data Management Plan.
- Participating in system and study validation processes, including the creation and execution of validation test documentation.
- Creating trial specific documentation as needed, such as CRF Completion Guidelines.
- Providing support for study team and investigational site staff regarding Electronic Data Capture systems.
- Initiating and participating in Clinical Data Management initiatives, to contribute to the continuous improvement of the standard processes and technologies utilized within the department.
- Assisting with data processor activities during times of peak workload.
- Providing data management trial support for the study Clinical Data Manager.
- Minimum 3 - 5 years clinical data review/cleaning experience, preferably in pharmaceutical research and development or related field.
- Preferred experience with relational databases, preferably Electronic Data Capture (EDC) systems.
- Oracle Clinical, Rave, or Inform systems preferred.
- Knowledge of computer system validation, in particular FDA 21 CFR part 11, desired.
- Must demonstrate the ability to interpret, evaluate and trouble-shoot issues pertaining to the data associate activities, to determine the appropriate actions necessary for ensuring that the tasks associated with cleaning are completed both accurately and efficiently.
- Working knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices.
- Excellent communication skills, both verbal and written, of English.
- Accurately and efficiently work towards quality results.
- Ability to work independently, as well as handle multiple diverse projects simultaneously, under tight time constraints.
- Independent decision making and implementation.
- Exceptional knowledge of MS Office products.
- Excellent communication, time-management, and organizational skills.
- Medical, Dental, Vision coverage (Company contributes significantly to premiums)
- 20 days PTO + 13 Paid Holidays
- 100% employer matching 401(k)
- Short & Long-term disability benefits
Benefits Offered?
- No
Bonus Offered?
- No
Travel Required?
- No
Experience:
- Mid-Senior level
Remote Job:
- Yes
Global Experience Needed?
- No
Specialized Experience Needed?
- No
Apply before:
- Apr 18, 2024
Company Overview
Peachtree BioResearch Solutions
Current Openings: 0
Over 10 years ago, Peachtree was founded to fill a perceived missing principle in typical CRO services. Where can I find a CRO that will partner with me, understand my challenges, and solve issues to keep my program on track? Filling this need requires experienced clinical research professionals. We focused on people – building an organization by investing in highly experienced personnel with broad therapeutic area expertise in a number of clinical trials. From single-center Phase I to global multi-center trials. Most all of our clinical personnel have both sponsor and CRO experience – allowing us to fully understand the issues our sponsor-clients face. We built a rock-solid processes and systems infrastructure to support the teams and this investment continues today – always seeking to improve our service. We also saw the opportunity to support an under-served segment of the market – emerging mid-sized companies. We felt they could benefit from access to highly-experienced teams that understand the challenges of limited resources and be flexible, reliable, and responsive. Most of all – provide solutions. So where is Peachtree today? 🍑 A full-service CRO offering project management, feasibility & subject recruitment, clinical site management & monitoring, data management, biostatistics, medical monitoring, medical writing, and clinical quality assurance 🍑 We are 80+ highly-experienced clinical research professionals with an average of more than 20 years relevant clinical experience 🍑 Our client roster continues to grow having worked with nearly 100 pharmaceutical, biotech, and medical device companies providing full-service clinical trial support to niche services 🍑 Continued investment in best-in-class systems such as IBM Clinical for EDC, Veeva Vault for eTMF, ZenQMS for quality management and training, and Oracle for CTMS.
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