La Mesa, CA
Contract Clinical Data Manager
Looking for a Clinical Data Manager in San Diego, CA. This is a Hybrid position and requires some onsite availability.
Client Company, is an in-vitro diagnostics company dedicated to improving the diagnosis of high-risk medical conditions through the identification and validation of protein biomarkers that can serve as the basis for novel in-vitro diagnostic tests.
JOB SUMMARY:
Reporting to the Associate Director, Data Management, this role will have responsibility for supporting data management activities for the Nephroclear CCL14 study start-up, conduct and close-out activities.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Manage the delivery of high quality data from study start through execution and study closeout on several projects.
Perform data quality control and quality assurance processes and manage the query resolution process for assigned studies.
Participate in the development of study databases and validation & derivation procedures and documentation of their specifications.
Develop CRF guidelines and data management plans.
Perform testing and validation of databases and data entry screens to ensure compliance with protocol and procedures.
Develop training material and provide EDC training for internal users and site personnel.
Identify project-specific reports and data listings and assist in their development.
Support clinical per GCP and ICH standards and regulations.
Interact with third-party vendors such as CROs, supply vendors and central laboratories to carry out data management or clinical operations tasks for clinical studies.
Performs sample reconciliation of clinical samples, identifies discrepancies and oversees resolution of discrepancies.
Responsible for ensuring compliance with applicable Client Company policies and procedures across the organization.
Maintain and enter Laboratory normals within Medidata Rave.
Verify data on subject adjudication in Medidata Rave.
Responsible for ensuring compliance with applicable Client Company policies and procedures across the organization.
Performs other duties & projects as assigned.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED:
BA / BS Degree in related field, or an equivalent combination of education and work experience, preferred.
At least 6 years of hands on experience in data management activities for multiple and/or complex clinical studies, preferred.
Experience with web-based Electronic Data Capture (EDC) Medidata Rave preferred.
Familiarity with relational databases.
Knowledge of industry standards and applicable regulatory rules and guidelines; e.g. ICH and GCP.
Proficient with Microsoft Office Suite (Word, Excel, PowerPoint and Access).
Excellent interpersonal and communication skills (written and verbal).
Ability to prioritize projects and workloads.
PHYSICAL DEMANDS:
While performing the duties the employee is:
Constantly required to reach computers and other office equipment
Frequently required to communicate with others
Frequently required to sit
Frequently required to use fine manipulation and simple grasping in order to utilize the computer and other standard office equipment such as telephone, fax machines, copiers, etc.
WORK ENVIRONMENT:
Employee frequently works in an office environment with a moderate amount of noise and activity. The work environment is fast-paced and demanding. Work weeks exceeding 40 hours are required as necessary.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit {apply below}to contact us if you are an individual with a disability and require accommodation in the application process.
Client Company, is an in-vitro diagnostics company dedicated to improving the diagnosis of high-risk medical conditions through the identification and validation of protein biomarkers that can serve as the basis for novel in-vitro diagnostic tests.
JOB SUMMARY:
Reporting to the Associate Director, Data Management, this role will have responsibility for supporting data management activities for the Nephroclear CCL14 study start-up, conduct and close-out activities.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Manage the delivery of high quality data from study start through execution and study closeout on several projects.
Perform data quality control and quality assurance processes and manage the query resolution process for assigned studies.
Participate in the development of study databases and validation & derivation procedures and documentation of their specifications.
Develop CRF guidelines and data management plans.
Perform testing and validation of databases and data entry screens to ensure compliance with protocol and procedures.
Develop training material and provide EDC training for internal users and site personnel.
Identify project-specific reports and data listings and assist in their development.
Support clinical per GCP and ICH standards and regulations.
Interact with third-party vendors such as CROs, supply vendors and central laboratories to carry out data management or clinical operations tasks for clinical studies.
Performs sample reconciliation of clinical samples, identifies discrepancies and oversees resolution of discrepancies.
Responsible for ensuring compliance with applicable Client Company policies and procedures across the organization.
Maintain and enter Laboratory normals within Medidata Rave.
Verify data on subject adjudication in Medidata Rave.
Responsible for ensuring compliance with applicable Client Company policies and procedures across the organization.
Performs other duties & projects as assigned.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED:
BA / BS Degree in related field, or an equivalent combination of education and work experience, preferred.
At least 6 years of hands on experience in data management activities for multiple and/or complex clinical studies, preferred.
Experience with web-based Electronic Data Capture (EDC) Medidata Rave preferred.
Familiarity with relational databases.
Knowledge of industry standards and applicable regulatory rules and guidelines; e.g. ICH and GCP.
Proficient with Microsoft Office Suite (Word, Excel, PowerPoint and Access).
Excellent interpersonal and communication skills (written and verbal).
Ability to prioritize projects and workloads.
PHYSICAL DEMANDS:
While performing the duties the employee is:
Constantly required to reach computers and other office equipment
Frequently required to communicate with others
Frequently required to sit
Frequently required to use fine manipulation and simple grasping in order to utilize the computer and other standard office equipment such as telephone, fax machines, copiers, etc.
WORK ENVIRONMENT:
Employee frequently works in an office environment with a moderate amount of noise and activity. The work environment is fast-paced and demanding. Work weeks exceeding 40 hours are required as necessary.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit {apply below}to contact us if you are an individual with a disability and require accommodation in the application process.
Recommended Skills
- Audio Equipments
- Clinical Works
- Communication
- Data Entry
- Data Management
- Data Quality
Browse other jobs