Centralised Clinical Team Lead (CCTL)
Location: Bangalore, India
Company: Fortrea
Department: Clinical Operations
Employment Type: Full-Time
Role Summary
The Centralised Clinical Team Lead (CCTL) is responsible for overseeing centralized clinical operations activities and supporting global clinical trials through effective trip report review, risk management, quality oversight, and process improvement initiatives. The role acts as a key liaison between Clinical Research Associates (CRAs), Clinical Trial Leads (CTLs), Project Managers (PMs), and global study teams to ensure compliance with ICH-GCP, SOPs, and regulatory requirements.
The position also provides leadership in training, mentoring, quality review, issue resolution, and operational excellence to support successful clinical trial execution.
Key Responsibilities
Clinical Trial Oversight
Support management of complex clinical projects under Project Managers and Clinical Trial Leads.
Ensure site monitoring activities are conducted in compliance with:
ICH-GCP Guidelines
Regulatory Requirements
Fortrea SOPs
Clinical Trial Protocols
Monitor study progress and support achievement of project milestones.
Assist study teams in ensuring trial quality, compliance, and timely execution.
Trip Report Review & Quality Oversight
Perform comprehensive review of monitoring trip reports.
Ensure trip reports meet quality and compliance standards.
Implement best practices for trip report review processes.
Conduct quality checks and identify trends, risks, and compliance gaps.
Ensure consistency across monitoring documentation.
Risk Management & Issue Resolution
Proactively identify:
Study Risks
Protocol Deviations
Compliance Issues
Operational Challenges
Escalate issues through appropriate governance channels.
Coordinate timely issue resolution with:
CRAs
CTLs
Project Managers
Study Teams
Support CAPA implementation and tracking.
Clinical Operations Coordination
Act as primary communication point for:
Global CTLs
Project Managers
Clinical Operations Teams
Communicate study trends, safety concerns, and operational risks.
Facilitate cross-functional collaboration to support trial delivery.
Ensure effective communication across global study teams.
Process Improvement & Operational Excellence
Identify opportunities to improve clinical operations processes.
Lead implementation of process improvement initiatives.
Develop and update:
Trip Report Templates
Review Guidelines
SOPs
Work Instructions
Support continuous improvement programs.
Training & Mentorship
Mentor and train new CCTL team members.
Conduct quality review of trainee work.
Develop training plans and learning materials.
Ensure training documentation remains current.
Serve as Subject Matter Expert (SME) for Trip Report Review processes.
Clinical Quality & Compliance Support
Support:
Clinical Quality Checks (CQC)
eTMF Reconciliation
Protocol Deviation Reviews
Site Documentation Reviews
Assist with:
PSV (Pre-Study Visit) Materials
SIV (Site Initiation Visit) Presentations
CRA Training Activities
Maintain inspection and audit readiness.
Leadership & Stakeholder Management
Act as SME for centralized clinical operations.
Lead departmental initiatives and cross-functional projects.
Provide industry insights and operational recommendations.
Influence stakeholders to drive study success.
Support strategic clinical operations initiatives.
Required Qualifications
Education
One of the Following:
B.Sc
M.Sc
B.Pharm
M.Pharm
Pharm.D
BPT
BDS
Nursing
Medical Laboratory Technology
Life Sciences Degree
Allied Health Sciences Degree
Experience
10+ years of Clinical Research experience.
Minimum 2+ years of Trip Report Review experience (Mandatory).
Experience in Clinical Monitoring and Clinical Operations.
Strong knowledge of ICH-GCP and regulatory requirements.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Remote, India | Siliguri |Illinois :
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Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
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Oklahoma City |Puerto Rico :
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Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Koropi | Athens |Greece :
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Auckland |New Zealand :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
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Tallinn |Hà Nội :
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Ho Chi Minh City |Italy :
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