Project Manager Clinical Research
Resume:
K. Madhan Mohan____________________________________________________________________
Present Position: Assistant Manager-Site Operations, Excel Life Sciences, Hyderabad (From:Jun-2009)
Key Tasks:
• Identification of potential investigators/Sites and ongoing review/ development
• Identification of potential independent review board and ongoing review/development
• Conduct of ICH GCP,ICMR/DCGI guidelines, study specific training on regular basis at the sites
• Scan patients data and short listing of patients
• Help the investigator in screening patients
• Assisting investigators in Informed Consent process, coordination and management of laboratory samples,
courier and follow-ups of lab reports
• Drug accountability and dispensing at the site
• IVRS for patient randomization in randomized studies
• Investigational project management, dispensing, temperature monitoring and accountability
• Ensure compliance of project specific schedule activities
• Ensure compliance of SOPs (both internal & external as applicable)
• Preparation, attendance & follow up of Audit
• Trial close out: Preparation attendance and follow up; forwarding the necessary information of site closeout to all
concerns
• Manage & develop investigators in respective region
• Verify the accuracy and validity of data entered in database; correct any errors
• Prepare tables,graphs, fact sheets, and written reports summarizing research results
• Submit reports & research findings to internal & external costumers
• Compiling verifying information or data
• Manage site CTAs and their payment milestones
• Manage patient travel reimbursement
Team Management:
• Ensure the communication to team members of the scope of work, timeline and project goals, technical
information and other inputs
• Hold team meetings/ discussions on a regular basis to responsibilities of team members to evaluate the
performance of each individual
• Communicate to project manager for any needs or concerns regarding level of training or performance of team
members
• Timely suggestions/feedback on the team members to the Project Manager
• Ensure timely reports to project manager
Project specific:
PI/Site identification, assess manpower need & infrastructure capabilities, ensure timely enrollment
Interact with Sites: Interact with PIs and other study members on a regular basis, discuss potential issues and suggest corrective action
Provide feedback/inputs to operations, regarding the process of a study
Other Activities:
• Conduct internet-based search
• Conduct trial feasibilities in the region
• Participate & conduct Cross Referral activities as per project/study requirements
• Observing, receiving, and other wise obtaining information pertaining to Clinical Trials from all
relevant sources
• Regulatory updates - Educate investigators & Clinical research professionals
• Utilization of existing contacts (Sites, Investigators, industry, Vendors); & further development of database
• Mentoring team members in terms of improving skills, knowledge and to have a competitive edge in their
performance
• Travelling within region and assigned sites
• Any other assignment given by the management time to time
Past Experience:
Oct-2008 - Jun-2009: Sr. Clinical Research Coordinator-Excel Life Sciences, Hyderabad.
Jul-2007 - Sep-2008: Clinical Research Coordinator-Excel Life Sciences, Hyderabad.
Dec 2005-Jul-2007: worked as Sr. Clinical Research Assistant (Study Coordinator).CARE Hospital, Hyderabad
Mar 2003 - Nov-2005: worked as Clinical Research Assistant (Study Coordinator).CARE Hospital, Hyderabad.
EDUCATIONAL QUALIFICATIONS:
EXAMINATION
PASSED BOARD/ UNIVERSITY INSTITUTE YEAR OF PASSING
MBA Osmania University Distance Education 2011 (Results are awaited)
Industry Diploma in Contract research & Clinical Trials Private Bioinformatics Institute of India(BII) Jul 2006
P.G. Diploma In Bioinformatics Private Bioinformatics Institute of India(BII) Jan 2006
B.Sc Micro Biology Osmania University M.N.R. Degree College Mar-2002
Certifications & Training:
Diploma in E.C.G: March 2001 (Apex Educational society)
Managers Development Program: 7-Aug-09 to 9-Aug-09 (Excel Life Sciences) Noida
Clinical Excellence Programs:
Trained in Drug Development, ICH GCP, regulatory requirements in India, Site Management Logistics & Protocol Specifics
• -13th Feb 2006 (SIRO Clinpharm Pvt. Ltd), Hyderabad
• -18th Feb 2006 (Pfizer Pharma Ltd), Hyderabad
• -14th Jul 2006 (Avantis Pharma Ltd), Bangalore
• -14th June 2007(Bristol-Myres Sqibb), Hyderabad
• -09th July to14th July-2007 (Excel Life Sciences) Noida
• - 06th Oct 2008 (Excel Life Sciences), Hyderabad
• - 10th Feb 2009 (Excel Life Sciences), Hyderabad
Membership(S):
1. Member in Indian Society for Clinical Research (ISCR)
2. Member in Academy of Clinical Research Professionals (ACRP)
Research Skills:
A. Registries (Epidemiology):
1. Dec’2005 to Dec'2006: RAMI -Registry of Acute Myocardial Infarction (In Hospital)
2. Feb-2005 to Jan 2007 : Congestive Heart Failure Registry (in Hospital).
3. Jan-2003 to Apr-2003 : CREATE registry (international multicenter trial use Of LMWH in MI Patients)
B. International Multicenter Trials:
CADRDIOLOGY:
1. Effects of Reviparin, a Low-Molecular-Weight Heparin, on Mortality, Reinfarction and strokes in Patients with Acute-Myocardial Infarction Presenting with ST-Segment Elevation. Year - 2003 (Phase - III)
2. Use of Cardiac Device to prevent stroke in AF patients. Year -2005 (Phase-II /III)
3. A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral medication in the Treatment of Children, Aged 6-16 Years, with Pulmonary Arterial Hypertension. Year: 2004-07(Phase- II / III)
4. A Placebo-controlled, Double-blind, Parallel Arm Trial to Assess the Efficacy of drug for the Prevention of Cardiovascular Hospitalization or Death from Any Cause in Patients with Atrial Fibrillation/Atrial Flutter (AF/AFL).Year:2006-07(Phase-III)
5. A multinational, randomized double-blind placebo-controlled, parallel-group trial. In patients with NYHA II chronic systolic heart failure population. Year: 2006-07 (Phase -III B)
6. A Randomized Dose Ranging Study of drug including Active Control, in Patients With Unstable Angina or Non-ST-Segment Elevation Myocardial Infarction Scheduled to Undergo Percutaneous Coronary Intervention Year: 2006-07 (Phase-II)
OPTHALMOLOGY:
1. A Double-Masked, Placebo-Controlled, Parallel-Group, Multi-Center, Dose-Ranging
Study with an Optional Extension to Assess the Efficacy and Safety of Study drug
as Therapy in Subjects with Active Sight Threatening, Non-Infectious Anterior
Uveitis, Year: July-2007 to Jun-2009(Phase III).
2. A Double-Masked, Placebo-Controlled, Multi-Center, Parallel-Group, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of Study drug as Therapy in Subjects With Clinically Quiescent Sight Threatening, Non-Infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis, Year: July-2007 to Jun-2009(Phase III).
3. A Double-Masked, Placebo-Controlled, Parallel Group, Multi-Center, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of Study drug as Therapy in Subjects With Active Sight Threatening, Non-Infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis, Year: July-2007 to Jun-2009(Phase III).
4. A Multinational, Multicenter, Randomized, Double-Masked, Study Assessing the Safety and Efficacy of Intravitreal Injections of study drug (three doses) for the Treatment of active, Non-Infectious Uveitis of the Posterior Segment of the eye, Year: Aug-2011 to Jul-2012 (Phase III)
ONCOLOGY:
1. A Multicenter, Open-Label, Phase II Study of drug for Efficacy and Safety in Patients
With Metastatic Breast Cancer .Year: Oct-2008 - May-2011 (Phase II)
2. Subjects with Lung Cancer, Year: Feb-2009 to Apr-2010 (Phase III)
3. A Multicenter, Open-Label, Phase II Study of drug for Efficacy and Safety in Patients
With Metastatic Breast Cancer .Year: May-2010 – Jul-2011 (Phase II)
ENDOCHRINOLOGY:
1.A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose- Ranging Study to Evaluate Efficacy and Safety of Study drug, a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus, Year - Oct-2009- Aug-2011 (Phase II / III)
2.A Multicenter, Multinational Extension Study to Evaluate the Long-Term Efficacy and Safety of study drug, a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults with Recent-Onset Type 1 Diabetes Mellitus, Year - Oct-2009- Apr-2011 (Phase II / III)
C. Audits attended:
1. Sponsor Audit for Study Primary pulmonary Hypertension (Dec-2006)-Cardiology
2. Sponsor Audit for study Uveitis (Sep-2009)-Ophthalmology
3. Sponsor Audit for study Breast Cancer (Sep-2009)-Oncology
4. EMA (European Medicines Agency) regulatory audit for the uveitis study (Sep-2010)-Ophthalmology
5. Sponsor Audit for study Breast Cancer (Jan-2011)-Oncology
Computer Proficiencies:
March 1997: Diploma in Computer Applications from National Computing Council.
Language(s) Known:
Language(s) Read Write Speak
English
Hindi
Telugu
Personal Details:
Date of Birth : 16-Aug-1979
Gender : Male
Contact Details:
Contact no. : +91-970*******
Email : *************@*****.***
PLACE: Hyderabad K. Madhan Mohan
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