| Clinical Data Management || Remote at Remote, Remote, USA |
| Email: [email protected] |
|
http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=1596973&uid= Hi, Hope you are doing well. This is Manpreet from 1 Points LLC. We are a global recruitment company with specialization in hiring IT professionals. Please go through the below job description and let me know if you are interested in the same. Role : Clinical Data Management Location : Remote Long term contract Technical/Functional Expertise Working knowledge and understanding of FDA and ICH regulations and industry standards and quality control principles. Experience with all phases of drug development. Solid experience in handling clinical data acquisition and management from external/3rd party vendors. May lead study level negotiation and agreement for data transfer or integration on behalf of the company. Should be able to function collaboratively (with some guidance) with all levels of employees; moderate supervision required. Knowledge of FTP tools like GlobalScape, clinical platforms like Veeva CDMS, Elluminate, and Veeva TMF will be a plus Data Acquisition: 1. Can you explain the process of clinical data acquisition from third-party vendors 2. How do you ensure the integrity and quality of the data acquired from external sources 3. What are some common challenges you face during data acquisition, and how do you address them 4. Describe a time when you had to set up data transfer agreements with a third-party vendor. What steps did you take to ensure compliance with company standards Data Collection Standards: 1. What are the key FDA and ICH regulations you must adhere to when collecting clinical trial data 2. How do you ensure that the data collected meets industry standards and regulatory requirements 3. Can you describe the process you follow to validate third-party data before integration into company systems 4. What quality control measures do you implement to maintain data accuracy and consistency Vendor Management: 1. Describe your experience in managing relationships with external vendors. How do you ensure effective communication and collaboration 2. How do you handle disagreements or conflicts with vendors regarding data standards or timelines 3. Can you provide an example of a successful negotiation you conducted with a vendor for data integration or transfer 4. What criteria do you use to evaluate and select third-party vendors for clinical data management Practical Scenarios: 1. Imagine you receive data from a vendor that does not meet the expected quality standards. What actions would you take to resolve the issue 2. How would you approach creating a new external data transfer agreement for a clinical trial study 3. What strategies do you use to maintain strong working relationships with internal stakeholders such as Clinical Data Management and Clinical Data Engineering 4. Describe a situation where you had to escalate an issue to CT3 leadership. What was the issue, and how was it resolved Here is the job description: Job Description Serve as the subject matter expert for the planning, set-up, and acquisition of external clinical data at the study level and manage study start-up, conduct, and close-out activities. Create external data transfer agreements, ensuring external clinical trial data are in alignment with company standards and specifications to support data integration, analysis, and reporting. Help and advise in setting up infrastructure for external data to flow into company clinical data pipelines. Responsible for validation of all 3rd Party Data generated in clinical trials into company clinical data pipelines. Develop strong and productive working relationships with key stakeholders like Clinical Data Management, Clinical Data Engineering, Standards, and other Study Execution Team members. Participate in preparing function for submission readiness and may represent Clinical Trial Tools & Technologies (CT3) group in a formal inspection or audit. Represent the company in interactions with key external partners as part of the company CT3 3rd Party Data Acquisition team. Responsible for timely submission and ongoing maintenance of study-related 3rd Party Data Acquisition documentation in TMF. Follow procedural documents and participate in reviewing and updating documents to ensure they are reflective of industry standards and regulatory requirements and include optimal processes. Liaise with and review work delivered by external partners (e.g., laboratories, eCOA providers, technology providers, etc.) performing services on behalf of the company. Escalate issues to CT3 leadership appropriately. Thanks & Regards Manpreet Singh Technical Recruiter | 1Point System LLC www.1pointsys.com [email protected] https://www.linkedin.com/in/manpreet-singh-a475301a5/ 115 Stone Village Drive Suite C Fort Mill, SC 29708 An E-Verified company | An Equal Opportunity Employer -- Keywords: information technology golang South Carolina Clinical Data Management || Remote [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=1596973&uid= |
| [email protected] View All |
| 08:29 PM 25-Jul-24 |