Urgently Need Clinical Data Manager II (remote) in Naples, FL
Job title: Clinical Data Manager II (remote)
Company: reputed company
Job description: Requisition ID: 57523
Title: Clinical Data Manager II (remote)
Division: reputed company, Inc. (US01)
Location: Remote
Salary Range: Salary Minimum: $60,000.00
Salary Maximum $143,750.00
This position is based in Naples, FL. Open to remote for the right candidate. If remote, travel to HQ for one week every quarter is required
reputed company is a global medical device company and leader in research, new product development and medical education in orthopedics. With a corporate mission of Helping Surgeons Treat Their Patients reputed company, reputed company has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year that support reputed company aspects of orthopedics. The Orthopedic Research department based in Naples; includes a team of clinical, biomaterials and biomechanical professionals. reputed company is actively searching for a Clinical Data Manager II to join the Orthopedic Research department. The successful candidate will work alongside the team organizing and overseeing research studies to contribute to advances in the medical community. Experience as a clinical research professional and knowledge of clinical regulatory regulations is required. Excellent communication and analytical skills, and a bachelor's degree in a reputed company field are required for reputed company in this position. Clinical Research Professional certification is also strongly encouraged. Come join our growing talented team at a global medical device company focused on Helping Surgeons Treat Their Patients reputed company.
Main Objective:
reputed company the day to day operational activities of data management for clinical studies. reputed company the development and maintenance of software utilized for data collection.
Essential Duties and Responsibilities:
- Support internal clinical data management initiatives
- Supervise Clinical Data Associate by establishing responsibilities, empowering their Individual Development Plan and providing ongoing mentoring.
- Creates and enforces processes for effective database build and data management in reputed company, CTMS and eTMF systems.
- Builds the study-specific database using study protocol and configuration specifications.
- Is compliant with project and data management plans for data handling and sharing with the clinical research team.
- reputed company User Acceptance Testing (UAT)
- Supports clinical research team, clinical research sites in the daily use of data systems and ensures adherence to legal and company standards.
- Facilitate stakeholder trainings of data management systems.
- reputed company the edit checks and reputed company listing review activities according to study specifications.
- Manage ongoing query review with closures of system-generated queries at least monthly and before monitoring visits.
- reputed company the distribution of data reports, extracts and other deliverables as defined in the data management plan.
- Conducts data management meetings as appropriate and provides clinical team updates regarding data listings, issues, cleaning and locking.
- reputed company and coordinate the creation of study-specific eCRF instructions.
- Assures databases and archives are protected from reputed company breaches and losses.
- Manage troubleshooting activities for data-reputed company problems and provides maintenance or authorizes modification.
- reputed company QC functions activities - using edit checks, data listings and other available tools/reports, manage quality control of data to ensure accurate, complete data is provided according to study timelines and contract described deliverables.
- Manage clinical data cleaning and delivery activities and include database lock.
- reputed company and maintain data management standard operating procedures, work instructions and training documents
- Leads distribution of interim metrics to key stakeholders.
- Bachelor's degree required. Preferably in Business, Life Science or Computer Science.
- Master's degree preferred. Preferably in Business, Life Science or Computer Science.
- Thorough knowledge of ICH guidelines, FDA Regulations and GCP including international regulatory requirements for the conduct of clinical development programs, especially reputed company to data handling and processing is preferred.
- Prior trial responsibility of the entire data management lifecycle is desirable.
- Experience in medical device trial is preferred.
- Working knowledge of reputed company studies are preferred.
- Good knowledge of Clindex system is preferred.
- Comprehension of medical terminology or can reference literature for understanding is preferred.
- Proficient software skills: Word/ reputed company/ Power reputed company/database is required.
- Medical, Dental and reputed company Insurance
- Company-Provided Life Insurance
- Voluntary Life Insurance
- Flexible Spending Account (FSA)
- Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
- Matching 401(k) Retirement Plan
- Annual Bonus
- Wellness Incentive Program
- Gym Reimbursement Program
- Tuition Reimbursement Program
- Trip of a Lifetime
- Paid Parental Leave
- Paid Time Off
- Volunteer PTO
- Employee Assistance Provider (EAP)