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Job Description

Job Summary

RTL/Sr. RTL is responsible and accountable for deliveries of studies allocated to RCO unit, performing end to end study related project management for studies managed in-house with-in agreed timelines, budget and desired quality standards. For Outsourced study, RTL/Sr. RTL will be responsible to provide an efficient Sponsor Oversight and accountable for key deliverables and study success.

RTL/Sr. RTL is expected to adhere to required procedures and quality in compliance with Sun Procedural Documents, ICH-GCP and local regulations.

Area Of Responsibility

- Planning and Execution of trials as per agreed timelines, budget and ensuring Quality across processes.
- Planning and Facilitating HA submission in coordination with IRA team
- Perform Preliminary site feasibilities, ensure site database is updated on periodic basis with feasibility results
- Plan and Accountable for the conduct of Site Selection visits, ensure actions from SSV's are followed up.
- Planning and performing IRB submissions in an efficient manner to secure timely approvals, ensure IRB/IEC dossiers are prepared and submitted as per requirements.
- Ensure Translation process are followed up for all trial related documents
- Track all vendor related payments and ensure timely payments
- Negotiate study budgets with sites, ensure Clinical Trial Agreements are executed in timely manner
- Ensure CTRI related submissions and updates in a timely manner for respective projects. Facilitate SUGAM related submissions and updates with IRA team.
- Responsible for preparing all project plans prior to SIV and training trial teams on the plans. Ensure implementation of plans and updates if required during the course of trial.
- Ensure planning and conduct of Monitoring visits as per Monitoring plan, devise study specific remote monitoring plans and guidelines.
- Provide periodic updates to management on study progress, deliverables, risks and Quality.
- Collaboration and lead communication with cross-functional units (IRA, clinical sciences team, Quality, DM, and other stakeholders to ensure proper execution and conduct the study effectively .
- Ensure IMP supplies are adequate at depot and site level, coordinate promptly with IMP supply team for initial and resupply orders, manage IP supply scheme at site as per recruitment progress, ensure IMP supplies are received by sites in good condition.
- Management of all study supplies like Ancillary supplies, e-diaries, recruitment and retention materials, Lab kits, others
- Plan and track recruitment / retention strategies at study and site level, ensure recruitment risks are communicated pro-actively to management and actions are planned in a timely manner.
- Ensure compliance with data cleaning cycles, train and update CRA's on data cleaning requirements. And, ensure readiness for Data Base Lock as per planned dates.
- Ensure Closure of Sites as per defined process

- For Out-sourced trials:

- Provide efficient Sponsor oversight for trial Planning, Conduct, Closure, Quality Control and Payments and Budget controls.
- Ensure all Sponsor key deliverables (regulatory, recruitment, DBL, Quality, Operation and budget related) are met by CRO and advise management w.r.t foreseen risks and challenges.
- Plan mitigations and timely actions in collaboration with CRO team to avoid delays and potential risks.
- Ensure strong and effective communication maintained with CRO team.
- Train CRO staff as and when needed. Perform Co-monitoring activities and Quality checks periodically according to agreed plans and foreseen risks.

- Mentoring and Line Management of CRA's/SR. CRA's. Focus on Individual Development plans, provide timely feedback to team members on performance and improvement areas.
- Ensure effective delegation and allocations of tasks among team members.
- Ensure Goal settings, mid-year review and year end appraisals are completed for team member's with-in timelines.
- Play an active roles in preparation and managing Site and Sponsor Audits
- Manage Investigator meeting planning and conduct prior to start of trial and during trial if needed.

Act as key member for Inspection readiness working groups.

Geographic Scope/ Market

India Cluster

Budget (if applicable)

Regional Clinical Operations Unit Budget

Work Conditions

Full time

Physical Requirements

Presence at work

Travel Estimate

Frequent

Education and Job Qualification

Minimum graduation in biological sciences and allied domains. Added qualifications will be preferred

Experience

Should have at-least > 10 years of experience in Clinical Operations years and at-least 2 years of experience in similar capacity with-in clinical project management.