Sirisha Chagarlamudi
Langley,BC
Summary
- PMP certified Clinical Research Project Manager with a total experience of over 10 years in Clinical Research and Pharmaceutical organizations
- Good educational background with Profession diploma in Clinical Research, Bachelors in Pharmacy and Masters in Pharmaceutical analysis with sound knowledge in Clinical trials, therapeutic areas and scientific literature review
- 5 years of experience in managing global studies, early and late phase trials related to Oncology, specifically Hematology, solid tumors, breast cancer, Cystic Fibrosis and other therapeutic areas
- Efficient in maintaining Sponsor, CRO and site relationship at all stages of clinical study, from study feasibility check to project closure, providing study updates, responding to queries promptly, preparing project reports, arranging teleconferences/meetings to discuss project progress
- Good experience in contract management, preparation of business proposals, bid defenses, project specific agreements, confidentiality agreements, contract renewals, CRO outsourcing and vendor management
- Strong ability to handle multiple projects at a time, project initiation, project planning, implementation and tracking project activities with proactive approach and managing risks throughout the project life cycle
- Proficient in Microsoft Office tools such as Outlook, Word, Excel, PowerPoint and Project Management tools such as MS Project, Smartsheet, Concerto to effectively manage project timelines, review the study data, communicate between cross-functional teams and maintain records
- Efficient in overseeing vendor management and vendor systems to ensure successful completion of a clinical trial.
- Excellent written and oral communication skills, team playing spirit with strong analytical and problem-solving abilities
- Highly organized individual with experience working in a fast paced multiple project environment with positive work attitude, excellent employee relationship and good leadership qualities
Overview
11
11
years of professional experience
Work History
Clinical Operations Study Lead
ICON Clinical Research
05.2022 - Current
- Supporting internal and external CTM activities like study planning, start-up, conduct and closure of assigned clinical trials or study regions
- Creating detailed study timeline in MS Project, monitoring progress of timeline with cross-functional study team inputs
- Assisting program lead in the execution of operational strategy and supporting initial timeline development
- Initiating recruitment planning and enrollment tracking
- Planning and overseeing protocol training activities including CRA trainings and Investigator meetings
- Supporting review of approved trial budget(s) as assigned by program lead, including ongoing vendor invoice reconciliation and scope of work review; working cross-functionally to support vendor contract changes and reviewing revised scope and budgets
- Supporting program lead on cross-functional vendor identification; delegated set-up and oversight of vendor activities including deployment of vendor systems (EDC, IXRS, Central labs, Central Pharmacy etc.)
- Overseeing the set-up, completeness and audit readiness for Trial Master File (eTMF)
- Creating and maintaining ADR log and study progress trackers
- Developing study plans and study related manuals (monitoring plan, lab manual, pharmacy manual etc.) with inputs from cross-functional teams
- Drafting and posting study newsletters by collaborating with Clinical and Medical teams
- Performing end of study reconciliation of clinical and ancillary supplies and overseeing close-out tasks
- Overseeing and tracking clinical trial monitoring and reviewing monitoring visit reports
- Coordinating for external data reconciliation and data management
- Responsible for risk management including identifying risks, assessing the impact and collaborating to mitigate or monitor the risks identified
- Responsible for inspection readiness and quality management oversight at all times
Project Manager, Clinical Research Services
AXIS Clinicals USA
10.2020 - 04.2022
- Establishing and tracking overall study timelines, CDAs, Budgets and Milestones
- Organizing kick-off meetings, Budget meetings, project status and review meetings to initiate, track, review and resolve issues related to various project activities through the project life cycle
- Coordinating with IRB and regulatory authorities for study / site related submissions
- Assisting in the preparation and review of study reports and reviewing for accuracy, completeness and compliance with SOPs
- Interacting with cross-functional teams across multiple sites to identify any roadblocks and ensure timely execution of study activities
- Reviewing protocol, regulatory guidelines, SOPs, study specific manuals and procedures to make sure the study activities are carried out accordingly
- Identifying sites, overseeing site selection process, monitoring performance of investigational sites, reviewing visit reports, SAE reconciliation data and tracking risk based monitoring activities
Pharmacy Technician
London Drugs
11.2018 - 10.2020
- Receiving prescriptions from patients, verifying the required information and entering prescription details in the patient's file on Kroll
- Supporting Pharmacists in maintaining the Drug Inventory by checking the drug expiry and ordering the stock regularly
- Assisting the patients in picking up their medications and checking the health insurance coverage
- Responding to phone calls, providing necessary information or redirecting to the appropriate party
- Compiling daily statistics, the number of prescriptions received, and number of refills ordered
- Assisting Pharmacists in preparing and dispensing prescriptions
- Preparing prescription labels with information like patient name, clinic, medication and dosage instructions
Research Associate- Projects
Neuland Laboratories Limited
09.2017 - 10.2018
- Initiating projects by preparing project charters, defining project scope, and arranging kick-off meeting with cross-functional teams for a better understanding on the project deliverables
- Providing inputs to the managing director regarding any scope changes and related Capital Expenditure requirements for a successful and sustained outcome
- Training internal stakeholders and other staff about Project Management techniques and utilization of Project Management tools like MS Project and Concerto
- Developing and maintaining Customer relationships by demonstrating successful promotions and through professional communications
- Monitoring and reporting the project progress and any keys obstacles encountered during the project execution
- Implementing effective process to identify risks, to come up with mitigation strategies and to monitor risks throughout a project lifecycle
Senior Executive- Project Management
AXIS Clinicals Pvt Ltd
10.2013 - 09.2017
- Coordinating with Client/Sponsor and all internal departments from the receipt of project enquiry till project completion
- Responding to Sponsor and regulatory queries promptly during and after the study completion
- Maintaining records for IMP / bio-sample retention
- Coordinating Investigational Medicinal Product shipment for study conduct and bio-sample shipment for analysis by providing necessary documents, getting approvals and tracking the shipment
- Providing updates to Client/Sponsor on a regular basis
- Assisting regulatory auditors and Sponsors during audits and providing required information in a timely manner
- Preparing study timelines after coordinating with cross-functional teams on clinical phase schedule, bio-analytical phase, Pharmacokinetic and statistical analysis and report submission
- Supporting regulatory submissions by providing relevant study documents, coordinating with Independent Ethics Committee / Institutional Review Board for study conduct
Education
Master of Science - Pharmaceutical Analysis
University of Strathclyde
Glasgow, UK09.2011
Bachelor of Science - Pharmacy
The TamilNadu Dr MGR Medical University
Chennai, India09.2009
Skills
- Clinical Research expertise
- Proactive approach
- Problem-solving
- Process improvements
- Excellent communication
- Executive team leadership
Awards and Certifications
- Project Management Professional (PMP) certification through Project Management Institute (PMI), 2021
- Tri-Council Policy Statement; Ethical Conduct for Research Involving Humans Course on Research Ethics (TCPS2: CORE), 2020
- Participated in GCP (Good Clinical Practice) training by Association of Clinical Research Organization (ACRO) India on March 10th, 2017
- Participated in Symposium (An interactive meeting with Regulators in Pharma Industry) on Jun 10th, 2017
- Academic Excellence for the Academic years 2005 to 2009
- Professional diploma in Clinical Research from Delhi University, India in 2008
- Participated in National Seminar on “The Art of Scientific Writing” on 25th & 26th April, 2008
Timeline
Clinical Operations Study Lead
ICON Clinical Research
05.2022 - Current
Project Manager, Clinical Research Services
AXIS Clinicals USA
10.2020 - 04.2022
Pharmacy Technician
London Drugs
11.2018 - 10.2020
Research Associate- Projects
Neuland Laboratories Limited
09.2017 - 10.2018
Senior Executive- Project Management
AXIS Clinicals Pvt Ltd
10.2013 - 09.2017
Master of Science - Pharmaceutical Analysis
University of Strathclyde
Bachelor of Science - Pharmacy
The TamilNadu Dr MGR Medical University
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