What are the responsibilities and job description for the Validation/Quality Manager I - Clinical position at Katalyst Healthcares & Life Sciences?
Company Description
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description
Job Description:
- Single Point of Contact to the Therapeutic Areas (TA)/Clinical Trial Team for TMF related questions and serves as Subject Matter Expert on TMF Quality Control
- Maintain documentation of appropriate oversight of all external partner’s work specific to document management within the TMF
- Responsible for optimizing, maintaining, and rolling out TMF Quality Control training mechanisms
- Translate trial information, processes and regulations into TMF documentation
- Responsible for conducting specified quality controls on some essential clinical documents according to established processes
- Track progress to key quality indicators (KQIs)s, and overall compliance to TMF processes and regulations
- Oversight of TMF QC Specialists and monitor QC performed by the TMF QC specialists on assigned trials
- Provide training/mentoring to the TMF QC Specialists on TMF processes, reconciliation/QC
- Maintain documentation of appropriate oversight Of Vendor TMF Technical Quality Control Personnel specific to document management QC within the TMF
- Single Point of Contact to the CTT for their assigned trials
- Provide CTT with TMF QC reports and assist with TMF related questions (e.g. TMF Table Of Content)
- Accountable for performing data analytics, identifying data issues / concerns, and facilitating the CTT in solving and implementing systemic solutions
- Proactively “pull” information during the set-up, execution, and close-out phases from accountable CTT members.
- Participate in CTT meetings as needed, responsible for the training of CTTs on TMF and implementation of best practices within CTTs
- Monitor the CTT compliance with TMF process within a trial in a timely manner
- Accountable for generating and managing the TMF Filing plan and TMF QC Reports
- Contact point to secure access to eTRAC system
- Serve as Subject Matter Expert on TMF training materials, processes and tools (eg. Clinical Document Management system, user Manuals for eTRAC)
- Participate and/or may lead some meetings related to TMF processes and trainings (eg TMF QC Compliance Review Meeting).
- As a TMF QC Management & Oversight representative, may participate in global cross-functional business process performance or clinical development improvement initiatives.
- Participate in the on-boarding, mentoring and training of new staff.
- Experience in cross-functional, multicultural and international clinical trial teams; able to work independently.
- Ability to lead globally distributed matrixed teams
- Good knowledge of clinical development process, regulatory requirements and GCP. Client experience in these areas is preferred.
- Excellent understanding of system data structures and Clinical Document Management System functionality
- Ability to learn new systems readily
- Strong computer skills (EXCEL, MS Word) required
- Excellent attention to accuracy and details
- Excellent communication, organization and tracking skills.
- Strong operational skills and demonstrated ability to meet timelines.
- Proven networking skills and ability to train colleagues.
Education:
- Bachelor’s degree in life science/healthcare is required with minimum 4 years’ experience in clinical operations and / or clinical systems management or
- Associate degree required with minimum 6 years’ experience in clinical operations and / or clinical systems management
Additional Information
All your information will be kept confidential according to EEO guidelines.
