Smita James
Cincinnati,USA
Summary
Experienced Clinical Trial Project Manager with a strong background in clinical operations, vendor oversight, and cross-functional collaboration in early and late-phase clinical trials. Skilled in Good Clinical Practice (GCP), ICH guidelines, and regulatory compliance. Proven ability to manage clinical timelines, budgets, and quality standards while driving operational efficiency. Adept at leading teams, mentoring junior staff, and navigating complex trial execution challenges to deliver high-quality results.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Project Manager II-Early Development and Clinical Operations
CinRx Pharma
09.2023 - Current
- Collaborate with the Early development and operational project team members to oversee clinical study vendor(s) to ensure compliance with the contracted study specifications.
- Lead the Early development and Clinical Operations team (as applicable) and cross-functional clinical trial team in the planning, execution, and reporting of clinical trials ensuring alignment of activities with study timelines, budgets, SOPs, ICH, GCPs, and applicable regulatory requirements.
- Proactively identify and resolve operational issues/processes to ensure achievement of study milestones, data quality, and data integrity; escalates study-related issues appropriately to Clinical Operations leadership in a timely manner.
- Interact with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Drug Safety and Pharmacovigilance, Clinical Supply, and Clinical vendors (e.g., central lab, CROs vendors) to support clinical trial activities.
- Manage clinical study timelines, budget by utilizing the appropriate project management tools, select and manage vendors, manage vendor contracts, and ensure expenditures are within budgetary guidelines.
- Ensure recruitment targets are met and review enrollment at the site level including responsibility for coordinating the approval of enrollment exceeding above site targets per protocol/contract with senior management; responsible for coordinating contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan.
- Organize and manage internal and external team meetings, investigator meetings, and other trial specific meetings.
- Develop and/or facilitate the development of the Sponsor study oversight plan, including study plans and documents, as required; review site study documents (e.g., informed consent template and study tools/worksheets), investigator contracts, and site payments as required; accountable for Sponsor Oversight Activities.
- Participate in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function.
- Support and/or facilitate the training of junior level Clinical Operations members.
- Set objectives of the core project team according to agreed upon contract, strategy and approach, effectively communicate and evaluate outcomes.
- Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
- Manage risk (positive and negative) and contingencies proactively and focus on the outcome and implementation of action plan.
- Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans.
Project Manager I-Clinical Operations
CinRx Pharma
01.2023 - 08.2023
- Responsible for the oversight of day to day study operations for assigned projects working closely with the CRO and other selected vendors for the assigned project(s).
- Assist in the development of clinical assets from pre-clinical through late phase clinical trials.
- Assist with program-level strategy, timelines, trial design, and implementation (as applicable).
- Accountable for developing and managing project-level plans, timelines, and site budgets.
- Manage, facilitate and document project team meetings (e.g. meeting agenda, minutes, operational risk, action items and decision logs) to enable effective decision making.
- Manage study team communications to ensure cross-functional connectivity among study team members and supporting functional staff.
- Review, provide input and guide completion of CRO study related plans (i.e., project management plan, communication plan, monitoring plan, reg submission plans, training plans, risk mitigation plans, study close out plans, etc.).
- Interface with Clinical Programs Leads to ensure company assets are managed effectively.
- Evaluate work processes on an ongoing basis to identify inefficiencies and gaps and provide solutions to resolve identified issues.
- In partnership with other functional areas, participate and provide feedback to other plans (data management, medical monitoring/safety management plan, etc.); participate in UAT of systems as needed.
- Ensure all relevant study related documents are filed appropriately in virtual data room in a timely manner.
- Assist with study supply and drug management.
- Collaborate with external vendors and/or internal colleagues to ensure critical timepoints are met for regulatory submissions and CMC work, as appropriate.
Clinical Research Program Manager -Feasibility and QA
Gastro Health Research
10.2022 - 12.2022
- Represent and serve as the initial contact with study sponsor/CRO for feasibility assessment.
- Coordinate feasibility assessments and deliver high quality, accurate feasibility data to internal and external teams.
- Develop preliminary proposal strategy for site across various states.
- Present feasibility results to the investigators site.
- Handle initial site qualification and site initiation visits.
- Initiate and maintain Quality Improvement program and processes to monitor and maintain immediate and long-term goals to increase clinical research and improve overall workflow.
- Manage resources of assigned Clinical Research areas to accomplish specified goals/objectives.
- Supervise and manage Clinical Research staff; develop growth plans and evaluate roles regularly; implement cross training initiatives.
- Responsible for assisting in the interpretation and implementation of policies and procedures as they apply to assigned areas of responsibility. Recommend changes on policy/procedures as necessary.
- Advise, support, guide and provide consultation to faculty, physicians and department administrators on specific research administration activities and services as needed.
Site Director (OH) -Site Operations
Gastro Health Research Network
11.2021 - 09.2022
- Responsible for the oversight and management of over 30+ Gastrohealth Research Studies from startups to study closure.
- Represent and serve as the initial contact with study sponsor/CRO.
- Collaborate with in-house physician leaders in setting priorities and establishing deadlines and goals.
- Work collectively with local and central IRB to comply with FDA guidelines in relation to Clinical Research.
- Responsible for all clinical operations aspects for the assigned Gastro Health Network clinical studies from preparation to closure.
- Responsible for leading, guiding and overseeing the Sites and ensuring that the vendor access has been granted to the site.
- Providing input into and/or developing study related materials like Informed consent form, Protocol.
- Overseeing and tracking patient recruitment and pro-actively identifying ways to prevent recruitment delays.
- Ensuring that study Trial Master File is maintained and up to date at each Gastro Health site.
- Ensuring clinical studies are conducted in compliance with ICH-GCP and other applicable legislations.
- Conducting internal audit to identify protocol compliance issues ensure reliable quality data.
- Pro-actively identifying and solving issues in the assigned clinical studies and timely escalating them to the senior Management.
- Co-writing/maintaining SOPs within the Clinical Operations.
- Assist in planning, writing, and implementing the clinical study's goals and objectives.
- Initiate, develop, and write research related standard operating procedures.
- Provide accurate and up-to-date study information within CTMS and other relevant tracking systems; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.
- Lead feasibility assessment and selection of sites for study conduct.
- Assist with establishing the budget for trials.
- Manage Research staff composed of Regulatory staff, coordinators, and data manager to achieve maximum accrual, meet all deadlines and ensure patient safety.
- Completing the annual key performance Evaluation based on Key performance Indicator.
- Oversee training and development of staff.
- Initiating and managing clinical projects in accordance with all relevant guidelines, legislation, and SOPs.
- Monitoring the progress of the clinical trial in relation to the project plan and previously defined performance indicators in terms of quality and budget.
- Identify risks and develop and implement plans to mitigate risks in collaboration with team members and other stakeholders.
- Act as a daily point of contact for the sponsor and all members of the project team.
Senior Clinical Research Professional
Gastro Health Research
10.2020 - 10.2021
- Maintain awareness of status of all active studies.
- Ensure participant and study compliance.
- Serve as a resource for other clinical research professionals in all aspects of conducting a clinical trial.
- Collaborate with investigator(s) and coworkers to ensure proper progress and completion of clinical studies.
- Train new staff in preparation and conduct of clinical trials.
- Prepare, submit & maintain all regulatory submissions (proposed new studies, annual review, amendments, & adverse events) accurately & within a timely manner to all collaborative parties. Periodically self-audit records to ensure audit-readiness.
- Prepare, plan, & participate in all monitor visits, audits, & quality reviews (internal & external) in a professional manner.
- Oversee the review, correspondence & approval of human research protocols with all regulatory authorities, including study closeout.
- Determine which research protocols or issues have additional requirements, e.g., the need for review by additional divisions, regulatory agencies, or consultants, & coordinate the process to meet these requirements.
- Document the conduct of each protocol's regulatory activities in appropriate systems. Maintain up to date & accurate written & electronic records & files to support clinical research activities.
- Determine best method/s to identify potential participants for research protocol (advertisements, chart reviews, monitoring of clinic schedule, etc.) and prepare accordingly.
- Create and maintain a detailed tracking system for participants considered for enrollment.
- Conduct pre-consent screening to determine eligibility.
- Review consent form with participant and provide time for participant to consider study participation.
- Make recommendations to improve recruitment and retention to the study leadership. Engage study staff to assist in identifying and enrolling participants. Proactively identify and monitor barriers to recruitment and problem solve or innovate to overcome them.
- Compose, document, organize, and maintain all correspondence.
- Oversee and follow through on questions and issues that arise during study conduct.
- Serve to internal departments, clinical teams, regulatory agencies, physician's offices, city clinics, government agencies, academic centers, and other organizations.
- Create CRFs in consultation with other team members, as needed, using existing study data information to promote efficient data collection and data entry.
- Complete Case Report Forms (CRFs) and source documentation in compliance with all applicable guidelines for human research. Review CRFs to ensure completeness, accuracy, and compliance with Good Clinical Practice.
- Review documentation from sources to ensure accuracy. Enter data into various auditable databases or electronic data-capture systems and/or oversee data entry and validation to ensure accuracy, completeness of data collection process.
- Perform data cleaning procedures and quality checks to ensure accuracy of data. Support the data-management process for clinical research projects, including addressing data queries from data managers, project statistician, and sponsors.
- Assist in data analysis and maintain record keeping and data storage for clinical research studies. Maintain master database files for clinical research protocols.
- Prepare reports from validation studies of clinical research projects.
Clinical Research Consultant
Trinity Clinical Research Services
08.2016 - 09.2020
- Worked as a consultant for Clinical research and medical writing projects.
- Ensured content of regulatory document adhere to the regulatory guidelines.
- Coordinated production and distribution of draft and final document to the project lead and clients.
- Lead feasibility assessment and selection of sites for study conduct.
- Assisted with establishing the budget for trials.
- Supported Investigator sites training department by providing Training Modules for Clinical research, Clinical data management, Pharmacovigilance, BA/BE Studies, and drug regulatory affairs.
Pharmacovigilance Operations manager
Stellence Pharma Science
04.2014 - 07.2015
- As a Pharmacovigilance Operations Manager, has been involved in development and implementation of Pharmacovigilance Software based on Argus platform for training purposes.
Medical Writer Project Lead
09.2013 - 04.2014
- As a Medical Writer Project Lead was responsible for working on the preparation of documents, management of information, maintenance of files, and coordination of tasks across multiple Projects.
- Written and reviewed nonclinical and clinical sections in regulatory dossiers, reports, and responses to regulatory agencies.
- Ensured Study data and reports are collected, reviewed, and finalized under the instruction of the pharmaceutical company.
- Involved in collecting, gathering, compiling, and preparing the materials needed for registration and submission to regulatory agencies.
Clinical Research Curriculum Director
09.2011 - 09.2012
- As a Clinical Research Curriculum Director, involved in development of online platform and Course Development for Clinical research, Clinical data management, Pharmacovigilance, BA/BE Studies, and drug regulatory affairs.
Clinical Research Manager
Trinity Medical, Dental and Research Center
01.2008 - 08.2010
- Overseeing the recruitment of other research participants.
- Working with marketing staff to Promote study participation and coordinating with researchers and other team members to ensure that research activities are carried out effectively.
- Adhering to the regulations defining the research participants’ eligibility criteria considering their health state, demographics, and other pertinent characteristics.
- Overseeing the development and completion of clinical research projects, including budgeting, IRB submissions, and legal compliance.
- Developing close ties with key people and other members of the medical and scientific communities to promote study enrolment.
- Managing the staff involved in clinical research, providing guidance, and mentoring to ensure top performance and career advancement.
- Ensuring that all data acquired for a study is accurate, complete, and following the law.
- Examining research designs and protocols to ensure they follow ethical standards and scientific considerations.
- Tracking the development of the study by reviewing information and reports from the research team.
- Examining data from clinical trials to look for trends or problems with study design or results.
- Generating reports on how research findings affect clinical practice.
- Reviewing and approving invoices for payments related to clinical research initiatives.
Research and Development specialist
Bangalore Institute of Dental sciences and Research center
04.2007 - 10.2007
- Oversee multiple observational dental research projects.
- Obtain and document the observational data.
- Facilitate the successful implementation of observational studies.
- Collaborate with other discipline involved in the research process.
Dental Surgeon/Senior Research Coordinator
MSS Hospital
08.2005 - 03.2007
- Oversee multiple clinical research projects, marketing, recruitment, scheduling of study participants while complying with the study protocol, timelines, and budget.
- Ensure institutional review board (IRB) submission, modifications, adverse events, and management is complete.
- Manage subject visits with Principal Investigators, examiners, study coordinators, clinicians, and patients to comply with the study protocol.
- Facilitate the successful implementation of the IRB approved protocol; review and execute the study protocols; assess study related needs; and provide input to facilitate implementation.
- Obtain and maintain the necessary training for safety, regulatory and data management.
- Prepare for regulatory reviews and respond to requests for regulatory compliance.
- Collaborate with other disciplines involved in the research process.
- Duties are determined by protocol-specific requirements as prepared by the PI and/or Sponsor and may include any research activity from submitting the protocol through study closeout.
Dental surgeon
DC Hospital
08.2003 - 07.2005
- Provide general dental care by cleaning teeth and filling cavities.
- Repair and remove problematic or chipped teeth.
- Correct teeth alignment or placement by installing braces.
- Protect teeth by using sealants or using whitening treatment.
- Recommend patients to dental specialists as needed for recommended procedures.
- Instruct patients about best practices in oral health and recommend the best brushes and toothpaste for their needs.
- Create models of crowns and dentures by taking measurements and making models.
- Review x-ray images captured in the office to determine the health of the teeth and potential areas of concern.
Education
MBA Pharma Management -
ICFAI
Bangalore, KA04.2015
Post Graduate Diploma in Clinical Reserarch And DM -
Karnataka State University
Ludhiana, Punjab12-2009
Bachelors of Dental Surgeon - Dentistry
Christian Dental College
06-2003
Skills
- Clinical Trial Management
- Vendor Oversight & Contract Management
- GCP / ICH Regulatory Compliance
- Site Monitoring & Trial Master File
- Risk & Quality Management
- Cross-Functional Collaboration
- Recruitment Strategy & Oversight
- Project Management Tools
- Systems Knowledge
- Communication & Leadership
Certification
- GCP Certification
- ACRP-CP
- ACRP-PM
Timeline
Project Manager II-Early Development and Clinical Operations
CinRx Pharma
09.2023 - Current
Project Manager I-Clinical Operations
CinRx Pharma
01.2023 - 08.2023
Clinical Research Program Manager -Feasibility and QA
Gastro Health Research
10.2022 - 12.2022
Site Director (OH) -Site Operations
Gastro Health Research Network
11.2021 - 09.2022
Senior Clinical Research Professional
Gastro Health Research
10.2020 - 10.2021
Clinical Research Consultant
Trinity Clinical Research Services
08.2016 - 09.2020
Pharmacovigilance Operations manager
Stellence Pharma Science
04.2014 - 07.2015
Medical Writer Project Lead
09.2013 - 04.2014
Clinical Research Curriculum Director
09.2011 - 09.2012
Clinical Research Manager
Trinity Medical, Dental and Research Center
01.2008 - 08.2010
Research and Development specialist
Bangalore Institute of Dental sciences and Research center
04.2007 - 10.2007
Dental Surgeon/Senior Research Coordinator
MSS Hospital
08.2005 - 03.2007
Dental surgeon
DC Hospital
08.2003 - 07.2005
MBA Pharma Management -
ICFAI
Post Graduate Diploma in Clinical Reserarch And DM -
Karnataka State University
Bachelors of Dental Surgeon - Dentistry
Christian Dental College