Nutan Mane
Oak Park,USA
Summary
Strategic Clinical Team Manager holding a medical degree and over 14 years of experience in overseeing complex clinical trials from start-up to close-out. Managed Phases II, III, and IV clinical trials across multiple therapeutic areas, ensuring all project deliverables meet contractual timelines, scope, and budget. Expertise in comprehensive project management including budget oversight, timeline management, and stakeholder communication. A committed and highly motivated professional with strong organizational and interpersonal skills, capable of working effectively both independently and as a collaborative team member.
Overview
23
23
years of professional experience
1
1
Certification
Work History
SENIOR CLINICAL TEAM MANAGER
THERMO FISHER SCIENTIFIC
03.2022 - Current
- Plan and manage clinical studies ensuring adherence to timelines, budget, quality, ICH GCP, and regulatory standards
- Responsible for vendor selection and management by tracking progress through monitoring their performance, cost effectiveness, timely delivery and quality
- Collaborate with cross functional teams to establish and implement clinical trial protocols and procedures and provides cross-functional oversight of internal project team members and deliverables
- Support in site selection, qualification, initiation, monitoring and close-out activities
- Develops study plans includes ICFs, monitoring plan, recruitment plan etc. to comply with protocol requirements, GCP guidelines and regulatory requirements
- Build strong relationship with the sites and stakeholders through effective communication
- Provide project-specific training, leadership and therapeutic knowledge to the clinical team to achieve project goals
- Review monitoring reports to ensure quality and resolution of site-related issues such as trending findings, deviations, serious breach etc.
- Reviews the study scope of work, budget and protocol content ensuring the clinical project team is aware of the contractual obligations and parameters. Responsible for CRA oversight to assess monitoring competencies for any issues identified mitigating to resolution strategies
- Implement strategic planning and problem-solving skills to propose and implement risk mitigations and make critical decisions regarding trial design, vendor selection and risk management
- Supports Clinical Development Audits, site audits and inspection and ensures CAPA followup and implementation for CRA and site identified issue/Issues
- Reviews the project oversight dashboards, clinical trial systems and Central Monitoring dashboards, to oversee Site data quality and integrity for data analysis to conclude final study report
- Oversees setting up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS) and Trial Master File (TMF) Contributes to investigator meeting preparation and execution
- Contributes to development of and oversees implementation of recruitment and retention strategies and accountable for global study delivery strategy for all deliverables
- Oversees and provides input to study drug and clinical supplies forecasting, drug accountability and drug reconciliation
- Develop operational plans tailored to protocol specifications ensuring adherence to quality and regulatory standards
- Lead and conduct investigator meetings and other study related meetings and participate in governance meetings, as necessary
- Participate in the recruiting and hiring process of CTMs, CRAs, PSCs, CTCs and supports their professional development
CLINICAL RESEARCH LEAD
PROVIDENCE HEALTH
06.2021 - 02.2022
- Served as the primary contact point between the Sponsor and the Investigational Site
- Managed and prioritized clinical deliverables for site management, data management and monitoring activities
- Conducted internal feasibility meeting for budget, site management planning and implementation of planned activities
- Provided leadership to the site staff to coordinate complex trials with high quality data and in timelines
- Ensured staff compliance of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocol
- Managed and supervised the investigators, site management, clinical and administrative staff, assuring that each clinical trial meets enrollment targets and is conducted in accordance with the clinical protocol(s) as approved by the Sponsor, all regulatory organizations, Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and regulatory guidelines
- Identified potential areas of risk, set priorities for internal reviews, site monitoring and review, and approve corrective actions needed
- Created risk mitigation strategies to meet quality and regulatory standard
- Coordinated and collaborated with various cross functional departments e.g. Clinical Operations, Recruitment, Human Resources, Central Services, to identify strategies for improved subject outcomes, site operating efficiencies, optimum subject experience, and risk assessment action plans
- Identifying areas for improvement and developing detailed process flows, policies, and procedures to ensure consistent quality data is collected across our sites
- Directed and managed clinical operations personnel, including hiring, performance reviews, and termination
- Monitored and reported protocol performance, timelines, and financial metrics on an ongoing basis to the management team, including the current status of the protocol
- Worked independently and proactively to coordinate all necessary activities as protocol requirements ensuring accurate data collection and maintaining study documentation
- Managed clinical trial site monitoring team metrics to ensure performance maximizes efficiency, quality, ICH/GCP adherence, and meets clinical trial and organizational goals
- Ensured performance meets expectations, as outlined in the oversight plan and/or other applicable plans
- Reviewed data to identify protocol deviations and risks to subject safety and data integrity
- Coached site team and ensured adherence to established guidelines
- Communicated effectively with internal and external stakeholders to foster strong partnerships and facilitate smooth trial processes.
- Support the development of creative processes, methodologies, data, and technologies that will ensure ongoing improvements in the delivery
CLINICAL STUDY MANAGER
SHREE HOSPITAL
12.2016 - 06.2021
- Supported the research organization by carrying out assigned tasks and projects leading to the achievement of departmental goals and objectives
- Collaborated with cross-functional study team and served as a liaison for the Sponsor, Study staff and PI
- Worked with clinical project teams and sites to support the completion of clinical trial documentation processes, negotiated on budgets and contracts, site management planning and implementation of planned activities
- Scheduled and participated in site qualification, site selection, initiation, interim and close out monitoring and auditing activities
- Oversaw the study level enrollment plan and assist in the identification and procurement of information required for creating and developing monitoring plan, data management plan, Informed consent template and CRF guidelines
- Worked with assigned CTAs to ensure study activities are documented via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and the Study Monitoring Plan
- Supported and monitored clinical trials to ensure sponsor and investigator obligations are met and in compliance with the currently approved protocol/amendment(s); applicable study procedure and ICH GCP guidelines.
LEAD STUDY COORDINATOR
UNIVERSITY OF MARYLAND MEDICAL CENTER
10.2013 - 02.2016
- Provided leadership to study staff to coordinate complex trials with high quality data and in timeliness
- Worked independently and proactively to coordinate all necessary activities as protocol requirements ensuring accurate data collection and maintaining study documentation
- Served as main contact for site management and cross functional teams to establish and implement protocol and procedures
- Scheduled and participated in site qualification, site selection, initiation, interim and close out monitoring and auditing activities
- Served as a Lead, coordinating all aspects of clinical research including feasibility, study initiation, recruitment, monitoring visits and close out activities
- Manage escalations and review of site budgets and contracts from CRO to ensure timely contract execution and study startup forecasts are achieved
- Support the development of creative processes, methodologies, data, and technologies that will ensure ongoing improvements in the delivery
Sr. CLINICAL RESEARCH ASSOCIATE
PIRAMAL PHARMA SOLUTIONS
04.2010 - 09.2013
- Scheduled and performed site qualification, site selection, initiation, interim and close out monitoring and auditing activities and prepares the trip report after the completion of visits
- Worked with clinical project teams and sites to support the completion of clinical trial documentation processes, negotiate on budgets and contracts, site management planning and implementation of planned activities
- Ensured completeness of clinical trial management system (CTMS) and Trial Master File (TMF) for assigned studies
- Obtained and reviewed essential documents to ensure completeness, accuracy, and regulatory compliance, and process essential regulatory, administrative documents, and Informed Consent Forms (ICFs)
- Communicated with operational team members and Investigator site staff to identify, assess, evaluate, and mitigate study risks, and manage with appropriate and successful resolution.
CLINICAL RESEARCH ASSOCIATE
H.J HEALTH SERVICES
02.2003 - 07.2005
- Monitored and ensured that protocol specific activities are conducted as per regulatory compliance and ICH GCP guidelines
- Assisted in site qualification, site selection, initiation, interim and close out monitoring and auditing activities as required
- Managed and coordinated all aspects of site management on assigned projects in accordance with ICH GCPs, FDA guidelines, local regulations, and PPD SOPs
- Conducted monitoring visits on a routine basis to assess protocol and regulatory compliance, review required essential documents and conduct investigational product accountability
Education
Bachelor's degree - Medicine and Surgery
Mumbai University
Mumbai, India01.2001
Executive Masters - Business Administration
Mumbai University
Mumbai, India01.2016
Skills
- Strong leadership skills
- Problem Solving
- Effective communication
- Flexible and adaptable
- Project Management
- Risk Management
- Resource and finance management
- Excellent technical skills
Affiliations
- Maharashtra council of Indian Medicine, Mumbai, Maharashtra, India
- ACRP, USA
Certification
- Project Management certification from Microsoft, 2025-01-01
- Specialization in Regulatory Compliance, University of Pennsylvania, 2021-01-01
- Licensed and Certified Medical Assistant and Phlebotomist, 2020-01-01
- Research Management and Leadership Training, University of Colorado, 2020-01-01
- Executive Management Development Program in Biotechnology, University of California, 2020-05-06
Professional Development
- CRG Biotech University Revitalization Certificate Program, Thermo Fisher Scientific USA
- PPD Vaccines COVID-19 Lecture, Thermo Fisher Scientific USA
- PPD Vaccines Academy Certificate Program, Thermo Fisher Scientific USA
- Thinking critically: Interpreting Randomized Clinical trials, Stanford University, USA
- Design and Interpretation of Clinical Trials, John Hopkins University, USA
- Ethics and Human Protection, ACRP, USA
- Data Management for Clinical Research, Vanderbilt University, USA
- Global Health certification, University of Copenhagen, USA
Therapeutic Experience
Respiratory, Infectious Disease , Opthalmology, Dermatology, Oncology, Cardiovascular, Immunology, Rheumatology, Rare disease and General Medicine
Regulatory Experience And Expertise
Experience with regulatory authorities and associated business teams
Additional Relevant Experience
- Part time Physician, 2005-2009
- Site Auditor- Responsible for preparation and implementation of Internal audit plan at site level.
- Scale/Patient Reported Outcome Measures
- Global health Score assessment
- Mental health Score assessment
- Physical health Score assessment
- Social health Score assessment
- Microsoft Office (Word, Excel, PowerPoint), CTMS, EDC, IRT, eTMF, eDiaries, Windows XP
Publications
Nutraceuticals in health management, Guest lecturer, University of Mumbai, Department of Research, 2005-01-01
Timeline
SENIOR CLINICAL TEAM MANAGER
THERMO FISHER SCIENTIFIC
03.2022 - Current
CLINICAL RESEARCH LEAD
PROVIDENCE HEALTH
06.2021 - 02.2022
CLINICAL STUDY MANAGER
SHREE HOSPITAL
12.2016 - 06.2021
LEAD STUDY COORDINATOR
UNIVERSITY OF MARYLAND MEDICAL CENTER
10.2013 - 02.2016
Sr. CLINICAL RESEARCH ASSOCIATE
PIRAMAL PHARMA SOLUTIONS
04.2010 - 09.2013
CLINICAL RESEARCH ASSOCIATE
H.J HEALTH SERVICES
02.2003 - 07.2005
Bachelor's degree - Medicine and Surgery
Mumbai University
Executive Masters - Business Administration
Mumbai University