- 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) 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 (e.g. Clinical Document Management system, user Manuals for eTRAC).
- Participate and/or may lead some meetings related to TMF processes and trainings (e.g. 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.
- 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.
#J-18808-Ljbffr
