OF THE ROLE
To take the lead on behalf of the CFSP Clinical Monitoring department, as representative on the Study Team for our function.
Responsible for operational management of a team of Monitors from start up, to ensure consistent monitoring quality and adherence to Trial timelines across all regions, through to database lock and site closures.
Internally : All members of CFSP Clinical Monitoring team, the Senior Global Trial Manager (SGTM) and members of the Study Team.
Externally : Sponsors, Vendors and suppliers as appropriate.
KEY TASKS & RESPONSIBILITIES
While projects vary, the typical responsibilities might include :
Monitor Study Progress and Follow-up on Outstanding Items and Actions
Manage Site Quality and CQRMP Process
Support Clinical Team with Monitoring Delivery and Site Issues
Develop Study Specific Training Tools / Content for IQVIA members - CRA, DLM and Site Report Specialist
Initial Point of Contact for CRA Team
Manage Compliance with Monitoring Plan and Study Procedures & Oversee Trip Report Review Process with SRS Team
Lead CRA Team Meetings
D rive the following :
Collection, input and communication of review of required study documentation (e.g. SMP.) and implementation of documents on a global level.
Provide information to the SGTM and communicate information from the Trial Team to the CFSP Clinical Monitoring group and management.
Validation and Follow-up of Key Study Milestones (e.g. start-up timeframe, recruitment targets, data collection, data cleaning, database closure) to be performed by all Monitors.
Organization of initial and refresher monitor training meetings with Trial Team in preparation for site selection and evaluation phase and subsequent trial phases (if deemed necessary e.
g. Monitoring Close out).
All Site Management activities (including constant feedback to the study team).
Responds to any Monitors questions and provides feedback, participates initiation visits, monitoring visits and close out visits as assigned or as necessary.
Managing a Question and Answer Log for all monitor queries and issues.
Review trends and provide comments on the centralised review of all Evaluation, Site initiation, Monitoring and Termination Visit reports.
Participate actively in Investigator Meetings (e.g. present CRF, GCP, monitoring planning and conventions and other study related procedures) if requested by Sponsor.
In conjunction with the SGTM, manage the TMF progress actively in order to have the TMF inspection ready at any time.
Acts as a communication channel to and from Monitors to ensure site management and site quality is maintained to all required regulatory and ethical standards throughout the study and provide regular feedback to the GTM and Study Team (as outlined in Communication / Escalation Plan).
Review and provide input on requested trial documentation, as allocated on the delegation of activities form :
Coordinate the generation and input of study related forms in accordance with standard templates (e.g. investigator selection customize site evaluation / assessment reports)
Organise CSFP Clinical Monitor conference calls (meetings if needed) in order to achieve study targets and provide training.
In addition, track attendance, generate meeting minutes in a timely manner and file any presentations given
Adapt and maintain GCM study tools incorporating the Monitors’, SGTM and Study Team’s input : E.g. CRF Completion and Monitoring conventions;
Monitoring Plan ;additional tracking tools and / or reports generated.
Study communication tool development and / or input (e.g. newsletter, Q&A document, submissions manual, submission related tools)
Finalization and implementation of site initiation activity plans : Classify issues, handle clinical issues, during data cleaning and query resolution and escalate appropriately.
Track progress of data cleaning and identify quality trends.In conjunction with the DLMs and the SGTM, develop a resourcing plan for the monitoring activities and follow upAnalyse and review the KPIs with respect to the monitoring quality aspects and trial related timelines
EDUCATION / LANGUAGES
As per applicable Job Description (i.e. Clinical Research Associate, Senior Clinical Research Associate, Principal Clinical Research Associate).
Advanced degree or equivalent education / degree in life science / healthcare recommended.
Excellent command of English.
PROFESSIONAL SKILLS & EXPERIENCE
At least 5 or 6 years working under CRA role.
Project Centric Delivery
Working with People
Adaptability / Flexibility
Ownership / Accountability
Proficient in multiculturalism
Ability to drive Change and Innovation
Strong results orientation
ROLE CONDITIONS :
This is a role, not a job.
No direct reports.
Office based / Home based in Mexico City and / or Buenos Aires.
Reduced number of visits at the site.
Reporting to Dedicated Line Manager.
Department : Clinical Functional Service Provider (CFSP), R&DS
Country : Region flexible.