Dubai, UAE as Clinical Team Leader
ClinTec International
Total years of experience :10 years, 8 Months
Since Apr '12 with ClinTec International, Dubai, UAE as Clinical Team Leader
Key Deliverables:
Track and manage the project's direct costs (budgeted vs actual in terms of hours), indirect costs (budgeted vs actual) and complete estimates
• Identify changes, quantify financial impact and communicate authorisation for the changes identified to the right person
• Monitor and review the study in terms of financial progress and compare to delivered milestones. Resolve any discrepancies of budget and ensure that project teams implement appropriate action plans.
• Communicate the project milestones reached with finance in order to invoice clients in a timely manner
• Communicate to Director Clinical Operations any budgetary issues as soon as highlighted and in situation when budget cannot be met
Management of projects
• Build a thorough understanding of contracts and scope of work
• Develop project schedules with detailed tasks with the support of the project team; identify responsible parties, staffing needs and timeframe for completion of list of deliverables and plan timeline in line with the client's commitments
• Assign and review on an ongoing basis the project team members' responsibilities and ensure resources are utilised effectively
• Monitor progress of the project from standpoint of milestones and deliverables and ensure the project team address any delays and imnplement appropriate action plan
• Inform the PM and Director Clinical Operations of any concerns or problems which may delay the project
• Ensure all projects stay on target with regards to clients' expectations and deliverables.
Trouble shooting
• Identify impending obstacles to the successful completion of the project, analyse information and develop solutions to address any identified obstacles.
• Facilitate the resolution of issues amongst team members and ensure open communication is favoured within the team
Proposal and Presentation
• Participate as required in proposal development and client presentation
• Prepare and present material for team meetings and Sponsor meeting
• Prepare and review department budgets for proposed clinical research trial bids
Miscellaneous
• Travel as required
• Perform other related duties as assigned
Mar '10-Mar '12 with ClinTec International, Dubai, UAE as Sr. Clinical Research Associate/Co-Project Manager
Key Deliverables: • Monitoring activities of CRAs to ensure early identification and resolution of issues, timely completion and reporting of tasks and communication of important study findings.
• Rendering assistance to CRAs in addressing comments raised by Sites regarding clinical trial agreements both in terms of legal and financial aspects. Liaising with sponsor/site as appropriate to achieve a mutually agreed outcome.
• Reviewing visit reports before these are released to the sponsor or internally to ClinTec Senior CRA/Project Manager if applicable.
• Overseeing recruitment across assigned sites, identify the key issues with slow recruiting sites and suggest/take corrective action to Sponsors and CRAs. Performing pre-study initiation, interim monitoring and close out visits as and when required.
• Ensuring adherence to protocol during site visits, verifying integrity of the data submitted on CRFs by source document verification, assisting CRAs and investigative sites with timely and accurate resolution of data queries, documenting ongoing site staff training and maintaining essential documents in the ISF.
• Providing prompt reports in accordance with sponsor SOPs, ICH-GCP and local regulatory requirements. Reporting any serious adverse events at sites to relevant sponsor contact and /or Regulatory Authority contact as appropriate.
• Undertaking responsibility for distributing SUSARs (Suspected unexpected serious adverse reaction) in accordance with IEC & local regulatory requirements. Ensuring adequacy of drug shipment and drug accountability (storage times and conditions are in compliance with GMP)
• Oct '11 Advanced Clinical Monitoring Workshop
• Nov '11 ICH GCP Refresher training in Clintec
PREVIOUS EXPERIENCE
Dec '06 - Feb '10 with Pharmaceutical Product Development India Pvt. Ltd., Mumbai
Joined as Research Assistant and rose to the position of Sr. Clinical Research Associate
Key Deliverables across tenure: As Sr. Clinical Research Associate (Apr '09-Feb '10)
• Mentored other CRA team members in order to ensure study of specific training for CRAs and that the sites were effectively managed.
• Facilitated building of partnerships and cultivating teamwork, communicating to the team in an open, balanced and objective manner.
• Tracked the flow of regulatory documents for all projects in order to co-ordinate and deliver the appropriate regulatory documents to meet regulatory and ethics committee submission date.
• Involved in initiating investigational sites to ensure that they had a thorough understanding of the clinical protocol and that they understood their obligations to conduct a clinical trial as required by applicable regulations.
• Ensured that the site personnel had a good understanding of the protocol, the investigational product and the requirements of the study and that they could fulfill their obligations to conduct the study accurately adhering to deadlines.
• Coordinated with the required persons for the assigned aspects of the clinical monitoring process in accordance with GCP and global SOPs to assess the safety and efficacy of investigational products and/or medical devices.
• Steered efforts towards developing collaborative relationships with investigative sites and client company personnel. Functioned as CSMG monitor for National Institute of Health (NIH) studies.
• Jan '07, Jan '08, Feb '09 ICH GCP and Schedule Y in PPD
• Jun '07 Clinical Foundation Program with PPD
• Feb '09 Clinical Site Monitoring Group Orientation for National Institute of Health
• Mar '10 Clinical Trial Process and SOP's with ClinTec
• Mar '10 ICH GCP in Clintec
As In-house Clinical Research Associate (Dec '06-Jun '07)
• Rendered day-to-day administrative support to the team.
• Maintained central study files for assigned projects and conducted investigator file reviews.
• Shouldered responsibility for corresponding regularly with Investigators, Team members and Sponsors on various project related issues.
• Involved in tracking important study data in the PPD database and offered organizational as well as administrative expertise. Accountable for the review and transmission of regulatory documents in accordance with FDA, GCP, WPD and SOPs. Assisted in the identification of potential investigators
• Was accountable for meeting applicable project timelines in accordance with the Master Contract
• Essayed a stellar role in training and mentoring new Project Assistants for the Department.
Trainings undergone
Duration Title
Dec '05 - Dec '06 with IDA Trading Foundation Ltd., Mumbai as Registration Officer (Drug Regulatory Affairs)
Jun '04 - Dec '05 with Lyka BDR International Ltd., Mumbai as Officer (Drug Regulatory Affairs)
Feb '04 - May '04 with Samruddh Pharmaceuticals, Tarapur as Production Chemist
CLINICAL TRIAL EXPERIENCE
Clinical Team Lead
Oncology: An open label, randomised phase III trial of XXXX and YYYY versus ZZZZ and YYYY in patients with metastatic HER2-overexpressing breast cancer failing one prior ZZZZ treatment.
Endocrinology: A 24-week phase III randomized, double-blind, parallel group study to evaluate the efficacy and safety of twice daily oral administration of AAAA + BBBB compared with the individual components of AAAA or BBBB in drug naive patients with type 2 diabetes mellitus
Cardiology: Global Registry on Long-Term Oral Anti-thrombotic treatment in patients with Atrial Fibrillation
Sr. Clinical Research Associate: Genetic Disorder: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Confirming the Efficacy and Safety of XXX in Patients with Gaucher Disease Type 1 (Global Trial)
Oncology: An open label, randomised phase III trial of XXXX and YYYY versus ZZZZZ and YYYY in patients with metastatic HER2-overexpressing breast cancer failing one prior YYYY treatment (Global Trial)
Genetic Disorder: Prevalence and Patient Experience with Condylomas Study (UAE, KSA, Bahrain and Russia)
Neurology: A phase IIIb, double-blind, placebo-controlled, multicenter, parallel group, Extension trial to evaluate the safety and tolerability of oral XXXX in subjects with relapsing-remitting multiple sclerosis who have completed trial (Global Trial)
Neurology: A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of XXXX New Formulation (XX mcg tiw and XX mcg ow) in subjects at high risk of converting to multiple sclerosis (Global Trial)
Neurology: A prospective, open-label, non-randomized, clinical trial to determine if XXXX (XXXX®) improves ambulatory measures in relapsing-remitting multiple sclerosis (RRMS) patients (Global Trial)
Medical Device: Patient Related OuTcomes with Endeavor versus Cypher stenting Trial (Global Trial)
Fertility: A phase IIIB, observational multicentre, multinational, randomized, open-label trial to compare the efficacy and safety of ovarian stimulation with XXX and YYY starting on Day 1 vs day 6 in women between 36 and 42 years of age undergoing assisted reproductive technique (ART) (UAE, KSA and Lebanon)
Hypertension: A prospective, multi-center, open-label, single arm study to assess the effect of XXX on Glycemic level in Type II Diabetic patients with suboptimal blood pressure control (UAE, KSA, Kuwait and Lebanon) ..
Infections/Parasitic Diseases: A Strategy Study of Immediate Versus Deferred Initiation of Antiretroviral Therapy for AIDS Disease-Free Survival in HIV-Infected Persons Treated for Tuberculosis with CD4 < XX Cells/mm3 (Global Trial)
Infections/Parasitic Diseases: A Phase II Randomized Comparison of Three Antiretroviral Strategies Administered for 7 or 21 Days to Reduce the Emergence of ABC Resistant HIV-1 Following a Single Intrapartum Dose of ABC (Global Trial)
Infections/Parasitic Diseases: A Limited Center Trial of the Adult AIDS Clinical Trials Group and the Pediatric AIDS Clinical Trials Group, Conducted in Collaboration with the HIV Prevention Trials Network (Global Trial)
Infections/Parasitic Diseases: A Phase IV, Randomized, Open-Label Evaluation of the Efficacy of Once-Daily Protease Inhibitor and Once-Daily Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Therapy Combinations for Initial Treatment of HIV-1 Infected Individuals from Diverse Areas of the World (Global Trial)
Infections/Parasitic Diseases: A Phase IV, prospective, randomized open-label evaluation of the efficacy of once-daily protease inhibitor- and once-daily non-nucleoside reverse transcriptase inhibitor-containing therapy combinations for initial treatment of HIV-1 infected individuals from resource-limited settings (Global Trial)
Infections/Parasitic Diseases: A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy plus HIV Primary Care versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 In Serodiscordant Couples (Global Trial)
Clinical Research Associate I/II
Endocrine/Metabolic: Clinical Research Associate on A Long-Term, Open-Label Extension Study to Investigate the Long-Term Safety of an antidiabetic agent in Subjects with Type 2 Diabetes (Global Trial)
Endocrine/Metabolic: A Multicenter, Randomized, Double-Blind, Study to Determine the Efficacy and Safety of the Addition of XXX versus Dose Titration from XXX to XXX of XXX Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Control on a Combination of XXX and XXX of XXX Therapy (Global Trial)
Clinical Research Associate I
Circulatory: A Phase 3, Active Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of an XXX in Preventing Stroke and Systemic Embolism in Subjects with Nonvalvular Atrial Fibrillation (Global Trial)
In House Clinical Research Associate
Oncology: A Randomized, Double-Blind, Multicenter Study of anticancer agent in the Treatment of Bone Metastases in Subjects with Advanced Breast Cancer (Global Trial)
Oncology: A Phase 3 randomized trial of chemotherapy with or without anticancer agent in patients with Metastatic and/or recurrent squamous cell carcinoma of the head and neck (Global Trial)
Circulatory: A Phase 3, Randomized, Double-Blind, Active-controlled, Parallel group, Multi-centre Study to Evaluate the Safety and Efficacy of an XXX In Subjects undergoing Elective Total Hip Replacement Surgery (Global Trial)
Since Apr '12 with ClinTec International, Dubai, UAE as Clinical Team Leader
Key Deliverables:
Track and manage the project's direct costs (budgeted vs actual in terms of hours), indirect costs (budgeted vs actual) and complete estimates
• Identify changes, quantify financial impact and communicate authorisation for the changes identified to the right person
• Monitor and review the study in terms of financial progress and compare to delivered milestones. Resolve any discrepancies of budget and ensure that project teams implement appropriate action plans.
• Communicate the project milestones reached with finance in order to invoice clients in a timely manner
• Communicate to Director Clinical Operations any budgetary issues as soon as highlighted and in situation when budget cannot be met
Management of projects
• Build a thorough understanding of contracts and scope of work
• Develop project schedules with detailed tasks with the support of the project team; identify responsible parties, staffing needs and timeframe for completion of list of deliverables and plan timeline in line with the client's commitments
• Assign and review on an ongoing basis the project team members' responsibilities and ensure resources are utilised effectively
• Monitor progress of the project from standpoint of milestones and deliverables and ensure the project team address any delays and imnplement appropriate action plan
• Inform the PM and Director Clinical Operations of any concerns or problems which may delay the project
• Ensure all projects stay on target with regards to clients' expectations and deliverables.
Trouble shooting
• Identify impending obstacles to the successful completion of the project, analyse information and develop solutions to address any identified obstacles.
• Facilitate the resolution of issues amongst team members and ensure open communication is favoured within the team
• Confidential ****
Proposal and Presentation
• Participate as required in proposal development and client presentation
• Prepare and present material for team meetings and Sponsor meeting
• Prepare and review department budgets for proposed clinical research trial bids
Miscellaneous
• Travel as required
• Perform other related duties as assigned
Mar '10-Mar '12 with ClinTec International, Dubai, UAE as Sr. Clinical Research Associate/Co-Project Manager
Key Deliverables: • Monitoring activities of CRAs to ensure early identification and resolution of issues, timely completion and reporting of tasks and communication of important study findings.
• Rendering assistance to CRAs in addressing comments raised by Sites regarding clinical trial agreements both in terms of legal and financial aspects. Liaising with sponsor/site as appropriate to achieve a mutually agreed outcome.
• Reviewing visit reports before these are released to the sponsor or internally to ClinTec Senior CRA/Project Manager if applicable.
• Overseeing recruitment across assigned sites, identify the key issues with slow recruiting sites and suggest/take corrective action to Sponsors and CRAs. Performing pre-study initiation, interim monitoring and close out visits as and when required.
• Ensuring adherence to protocol during site visits, verifying integrity of the data submitted on CRFs by source document verification, assisting CRAs and investigative sites with timely and accurate resolution of data queries, documenting ongoing site staff training and maintaining essential documents in the ISF.
• Providing prompt reports in accordance with sponsor SOPs, ICH-GCP and local regulatory requirements. Reporting any serious adverse events at sites to relevant sponsor contact and /or Regulatory Authority contact as appropriate.
• Undertaking responsibility for distributing SUSARs (Suspected unexpected serious adverse reaction) in accordance with IEC & local regulatory requirements. Ensuring adequacy of drug shipment and drug accountability (storage times and conditions are in compliance with GMP)
Dec '06 - Feb '10 with Pharmaceutical Product Development India Pvt. Ltd., Mumbai
Joined as Research Assistant and rose to the position of Sr. Clinical Research Associate
Key Deliverables across tenure: As Sr. Clinical Research Associate (Apr '09-Feb '10)
• Mentored other CRA team members in order to ensure study of specific training for CRAs and that the sites were effectively managed.
• Facilitated building of partnerships and cultivating teamwork, communicating to the team in an open, balanced and objective manner.
• Tracked the flow of regulatory documents for all projects in order to co-ordinate and deliver the appropriate regulatory documents to meet regulatory and ethics committee submission date.
• Involved in initiating investigational sites to ensure that they had a thorough understanding of the clinical protocol and that they understood their obligations to conduct a clinical trial as required by applicable regulations.
• Ensured that the site personnel had a good understanding of the protocol, the investigational product and the requirements of the study and that they could fulfill their obligations to conduct the study accurately adhering to deadlines.
• Coordinated with the required persons for the assigned aspects of the clinical monitoring process in accordance with GCP and global SOPs to assess the safety and efficacy of investigational products and/or medical devices.
• Steered efforts towards developing collaborative relationships with investigative sites and client company personnel. Functioned as CSMG monitor for National Institute of Health (NIH) studies.
As Clinical Research Associate I/II (Jul '07-Mar '08/Apr '08-Mar '09)
• Shouldered responsibility for conducting site visits to determine protocol, regulatory compliance and prepared required documentation.
• Spearheaded activities pertaining to study start-up, interim and closeout activities associated with clinical trials to ensure applicable timelines and metrics were met including regulatory, legal and financial aspects in accordance with FDA GCPs, ICH Guidelines and Global SOPs.
• Ensured accuracy of investigator files and prepared for audit readiness
• Carried out file reviews and maintained the study related binders as well as documents in proper binders.
• Steered efforts towards meeting applicable project timelines in accordance with the Master Contract.
• Handled clinical trial management systems (CTMS SEIBEL 7) effectively in order to ensure adequate communication to project team. Followed up with the Site Study Coordinator for study related documents.
• Performed task given by the Clinical Team Manager. Faced independent sponsor audit for two studies and functioned as a monitor for National Institute of Health.
As In-house Clinical Research Associate (Dec '06-Jun '07)
• Rendered day-to-day administrative support to the team.
• Maintained central study files for assigned projects and conducted investigator file reviews.
• Shouldered responsibility for corresponding regularly with Investigators, Team members and Sponsors on various project related issues.
• Involved in tracking important study data in the PPD database and offered organizational as well as administrative expertise. Accountable for the review and transmission of regulatory documents in accordance with FDA, GCP, WPD and SOPs. Assisted in the identification of potential investigators
• Was accountable for meeting applicable project timelines in accordance with the Master Contract
• Essayed a stellar role in training and mentoring new Project Assistants for the Department.
Trainings undergone
Duration Title
• Bachelor of Pharmacy from Vidyabharati College of Pharmacy, Amravati University, Maharashtra in 2003.
• Bachelor of Pharmacy from Vidyabharati College of Pharmacy, Amravati University, Maharashtra in 2003.