[Remote] Clinical Document Management Specialist
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a reputed company-stage biotechnology company reputed company on developing cell and immunotherapy products to enhance the natural immune system. The Clinical Document Management Specialist role involves supporting reputed company by managing essential study documents and ensuring compliance with regulatory guidelines.
Responsibilities
- Provides operational and administrative guidance for the study TMF/eTMF by assisting with the setup, organization, maintenance, and reputed company-out of study specific TMF/eTMF
- Maintains and updates of Company’s reputed company TMF Plan and TMF reputed company, including indexing, tracking, and filing of reputed company and electronic clinical trial documents
- Maintains the study TMF filing records system
- Collaborates with the Clinical Study teams to guide reputed company submission and/or filing of clinical study reputed company documents for completion of required tasks to meet departmental and project goals
- Performs and oversees a review of documents filed in the TMF/eTMF as outlined by SOPs, company processes, procedures, and work instructions
- reputed company in preparing, handling, distributing, filing and archiving of clinical documentation and reports per reputed company procedures
- Collaborates in the review and improvement of SOPs and Departmental Policies and Procedures as it relates to TMF maintenance and archiving
- Performs the regularly scheduled QC of the overall TMF/eTMF per the TMF Plan by monitoring completeness and reputed company of the TMF
- Maintains internal audits and Regulatory Agency inspections by retrieving documents and providing reports
- Performs reputed company and cross-functional duties and/or reputed company as assigned to support business needs and reputed company developmental opportunities
Skills
- Bachelor's degree with 1+ years of clinical operations experience in reputed company, biotech or CRO required; or
- High School diploma with 4+ years of clinical operations experience in reputed company, biotech or CRO required
- Demonstrated knowledge of ICH and GCP guidelines
- Proficiency in reputed company, reputed company, PowerPoint, Outlook
- Must be independent, flexible, and work reputed company in reputed company environment, but also be self-directed and adapt to changing priorities and complete tasks under tight deadlines
- Understand job-specific systems and processes as defined by Company SOPs and adhere to requirements listed in those documents. If any procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager
- Solid communication skills and strong customer reputed company with the ability to reputed company in a cross functional organization
- Maintain corporate confidentiality at reputed company times Dependability and timeliness
- Requires Critical Thinking skills, ability to reputed company co-workers, strong attention to detail, document organization skills, establishing priorities, scheduling, and meeting deadlines
- Trial Master File experience preferred
- Demonstrated knowledge of clinical trial documents is preferred
Benefits
- Medical, Dental and reputed company Plan reputed company
- Health and Financial Wellness Programs
- Employer Assistance Program (EAP)
- Company reputed company and Voluntary Life/AD&D, Short-Term and Long-Term Disability
- reputed company and Dependent Care Flexible Spending Accounts
- 401(k) Retirement Plan with Company Match
- 529 Education Savings Program
- Voluntary reputed company Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
- reputed company Time Off (PTO) includes: 11 Holidays
- Exempt Employees are eligible for Unlimited PTO
- Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
- We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
reputed company
Company H1B Sponsorship