About Codera
Codera is a Tang Capital company that provides in-house end-to-end drug development for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products.
Position Summary
The Senior Manager, Study Start Up & Records Management is responsible for assisting the study team by performing tasks related to study start-up, study/site management, clinical operations, inspection readiness and IRB/EC submissions of Aurinia’s clinical trials according to Standard Operating Procedures (SOPs), ICH-GCP guidelines and all applicable regulatory requirements. The Senior Manager, Study Start Up & Records Management will interface with Site Directors and the study team to support operational aspects of study start-up and execution.
Primary Responsibilities
- Support the execution of Phase I-IV studies including study start-up, site management and clinical operations activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s) and applicable study plans.
- Prepare and manage potential Investigator site lists, perform site outreach, assist in identifying clinical trial sites and contribute to site feasibility and site selection decisions.
- Act as main contact for study sites during start-up, including communicating with investigators and site staff on issues related to feasibility, essential document collection and IRB submissions.
- Support study start-up activities including the review of feasibility questionnaires, facilitation of site selection internal approvals, review of and facilitation of ICF internal approvals, and the completion of Investigator background checks.
- Prepare and review study documents (e.g., essential document packets, study plans, site Informed Consent Forms (ICFs), etc.) to ensure quality and consistency.
- Distribute and follow-up on start-up documents with sites. Review returned documents from the sites to ensure quality and completeness.
- Review and approve Essential Document Packages for site activation.
- Responsible for oversight of the central IRB in the United States/Canada
- Prepare and submit required study documents to central IRB
- Support central IRB annual reviews and study updates
- Communicate with central IRB as needed
- Support site IRB annual reports and updates, as needed
- Assist with the facilitation of the site contract and budget process
- Manage translation of necessary documents through translation vendor
- Support creation of and updates to study translation plan
- Support setup and management of Clinical Operations vendors (e.g. rater training, home healthcare).
- Facilitate and track vendor system access requests.
- Assist in Clinical Trial Management System (CTMS) maintenance including entry of study and site level updates, assistance with running reports and reviewing CTMS entry accuracy.
- Review study documents received from the study team for completeness and accuracy and upload to the Trial Master File (TMF).
- Assist with TMF quality reviews to ensure completeness, accuracy and timeliness of study documents to ensure TMFs are inspection ready at all times.
- Assist with oversight of study site training.
- Support inspection preparedness and study/site audit and/or inspection activities, as needed.
- Execute other duties as assigned.
Qualifications
- Bachelor’s Degree with minimum 5 years of relevant clinical trial experience required
- Minimum 3 years of feasibility and study start-up experience
- Experience and proven proficiency in CTMS and eTMF systems
- Experience with Veeva Systems preferred
- General knowledge of clinical site monitoring, feasibility and study start-up preferred
- Detail-oriented, organized, and committed to quality and consistency
- Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines
- Excellent team-interaction skills and ability to work successfully in global team settings
- Ability to work in a dynamic environment with a high degree of flexibility
- Possess a willingness and ability to work hands-on and with a sense of urgency in a fast-paced, entrepreneurial environment
- Must be proficient in Microsoft Word, Excel, and PowerPoint
The job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required. They may change, or new ones may be assigned at any time with or without notice.
The estimated annual base salary for this position is $130,000 - $160,000, commensurate with experience and skills.
Codera provides a comprehensive benefits package designed to support employees’ physical, mental and financial health and includes employer sponsored insurance plans including medical, dental and vision coverage; generous paid time off; retirement plan options and additional wellness andprofessional development programs.
Codera provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
Codera participate in E‑Verify. All newly hired employees are required to complete the E‑Verify process as part of their employment eligibility verification.
Salary: $130,000 - $160,000Originally posted on