NICE Institute for the New Born Hyderabad : Secretary to CEO

[Rajkumargautam]

NICE Institute for the New Born Hyderabad / Secunderabad : Secretary to CEO

Designation: Secretary to CEO
Experience: 2 - 5 Years
Location: Hyderabad

Job Description:
Provide all facets of secretarial and administrative support to CEO/ Executive Director. Assist in planning & organizing the needs and requirements of CEO/Director.

Desired Candidate Profile:
Basic Computer Knowledge, Typing skills, Excellent communication and interpersonal skills, good command of English. Basic management and business operations.

Company Profile:
NICE Foundation is an autonomous charitable trust. We seek to improve maternal health and combat infant and child mortality. Our interventions are School Healthcare Plan, Tribal Reproductive Child Health Programme and Institute for the Newborn.

Email Address: nicehrd@gmail.com

Keywords: Secretary to CEO

[Guest-IJT]

Name : Manishkumar D Shah
Email : manishds AT hotmail.com
Designation / Skillset : Head of Clinical Operations

Resume :

Educational Qualification :
Degree Year Class Subject University
Ph.D. 1999 NA
Applied Biology* Mumbai
M.Sc. 1993 First
Microbiology Mumbai
B.Sc. 1991 First Microbiology Mumbai
* Research Guide : Dr. (Mrs) R. A. Bhisey, Ph.D.
Management Education :
- Completed certificate course in Technology Management from Deakin University, Australia
- Participated in General Management program conducted by IIM Ahmedabad in December 2004
Fellowships and Awards :
1989 Secured second rank in first year B.Sc. in Khalsa College.
1992-1993 University of Bombay Merit Scholarship.
1993-1997 Junior Research Fellowship in Cancer Research Institute.
1997-1998 Lady Tata Memorial Trust Fellowship.
Technical Expertise :
Cell Biology :
Regular maintenance of established cell lines.
Flow Cytometry : Fixing, staining and analysing the samples.
Thymidine incorporation assays.
Chromosomal preparation from cell lines.
Carcinogenesis :
Cytotoxicity studies by colony formation assay.
Protein Biochemistry :
Spectrophotometric assays.
Separation of proteins by SDS-PAGE.
Western Blotting
Isoelectric focusing
Two-dimensional gel electrophoresis
Radioreceptor binding assays
Molecular Biology :
Genomic DNA isolation.
RNA isolation.
Agarose Gel Electrophoresis.
Northern Blotting
Microbiology :
Isolation, maintenance and biochemical characterisation of microbial isolates
Microbial bioassays for vitamins and antibiotics.
Plaque assays.
Familiar Techniques :
Iodination of proteins using 125I
Publications :
Shah M D, Ramchandani A G, Mahimkar M B, Potdar P D, Bhisey A N and Bhisey R A. “Effects of processed bidi tobacco on growth of Hamster Tracheal Epithelial Cells.” Toxicology Letters (published)
Professional Affiliations :
Member of Association of Clinical Research Professional (ACRP)
Member of Indian Society of Clinical Research (ISCR)
Other Affiliations :
Referee for Medical Microbiology M.Sc.thesis at Mumbai University
Mentoring :
Served as a protocol specific mentor for Osteoporosis study for the Middle East (Egypt) and Southeast Asian (Hong Kong, S Korea) countries and performed co-monitoring visits.
Computer Literacy :
Usage of Software packages like Microsoft word Office 97, Harvard Graphics, Microsoft Excel 97, Power point, and Microsoft Outlook, MS Project.
Summary : More than 12 years working in Clinical Research (mainly clinical operations) with the last 8 years as a Project Manager leading large global/multi-centric studies in India. Significant experience working in therapeutic areas like infectious disease, Osteoporosis, Oncology, Psychiatry, Cardiovascular, Allergy, Metabolic and Endocrine disorders.
Has been responsible for the Project Management of more than 25 Phase II/III global multi centric trials within India across 185 sites, and including over 2000 patients. Responsibilities have spanned the full duration of studies, from start-up to project closeout and review.
Last 4 years with the significant people management and line management experience and also having experience in the leadership role.
Work Experience :
..
November 1998-December 2000 : Worked in Pfizer Limited as a Clinical Research Associate in Clinical Research Division.
January 2001- May 2003 : Working in Pfizer Limited as a Clinical Project Coordinator in Clinical Study Management & Monitoring, Dev Ops
June 2003 – 31st January 2005: Working in Pfizer Limited as a Clinical Study Manager
01st February 2005 to 13th January 2006: Promoted in role and served as a Clinical Study Manager to higher middle management level
16th January 2006 TO 31st October 2006: Senior Project Manager, Quintiles Research (India) Private Limited
01st November 2006 TO September 2007: Senior Site Manager, BRISTOL-MYERS SQUIBB
01ST October 2007 TO 30th June 2008 : Manager of Site Managers & Data Managers, BRISTOL-MYERS SQUIBB
01st July 2008 TO 30th September 2009: Hub Unit Manager (Head of Clinical Operations),
BRISTOL-MYERS SQUIBB
01st October 2009 TO PRESENT: Head of Clinical Operations, Pfizer Limited
WORK HISTORY
Pfizer Limited, India, November 1998
- Performed pre-study site visits to find out the feasibility of carrying research activities/ successfully organised Investigator’s Meetings/ Performed site initiations/ closeout visits at various leading institutions/hospitals in India for various studies.
- Providing a key/invaluable support in business development activities like organising program for ‘Clinical Research In India’ at Delhi in September 2000.
- Timely support for providing the feasibility of five potential studies during the period of March 2000 to September 2000 and organising GCP workshops thus contributing for business development.
- Attended Vendor’s meeting/ Investigator’s for Osteoporosis study at various international locations like USA, UAE, AUSTRALIA, ITALY & TURKEY.
- Role profile modified from September 2004 wherein Clinical Study Manager served as a leader of the team with enhanced responsibilities. Currently Clinical Study Manager is responsible (final responsibility) for successful project deliveries to customers/stakeholders in co-ordination with monitoring group.
- Managed 09 clinical studies in the year 2005, in the area of Osteoporosis, infectious disease, hypertension, diabetes, asthma, heart failure, growth hormone (phase II-IV) in capacity of Clinical Study Manager responsible for overseeing, co-ordinating the conduct of the study and serving as protocol/training expert.
ROLE PROFILE IN PFIZER:
Strategic / Policy
1. Develop and consolidate clinical research capabilities in order to deliver high quality data from a diversity of clinical research projects (Phases II-IV).
2. Implement systems, procedures and controls to assure compliance to regulations, laws, ethical guidelines, and standard operating procedures for clinical research
Operational
- Liase with all customers to understand expectations and give feedback
- Project (clinical trials) planning and implementation
- Successful project delivery
- Coordinate/supervise clinical research associates (functional capacity), contract research organizations, local/central laboratories and other contractual services required for clinical study
- Developing, initiating, implementing and tracking project metrics to evaluate study conduct.
- Assist in organizing required resources
- Personal and Colleague development
- People Management
- Financial Management
- Technology Management
PROFILE IN QUINTILES:
- Management of project activities and project team members.
- Focal point for communication between sponsor and Quintiles
- Responsible for managing, timelines, quality and costs of projects deliverables
- Line management (11 direct reportees), including the development, grooming and bringing them to speed for the required role
PROFILE IN BRISTOL-MYERS SQUIBB:
- Management of project activities and project team members.
- Focal point for communication for global team
- Responsible for managing, timelines, quality and costs of projects deliverables
- Develop and consolidate clinical research capabilities for project delivery
- Implement systems, procedures and controls to assure compliance to regulations, laws, ethical guidelines, and standard operating procedures for clinical research
- Involved in supporting clinical research head for various non-project initiatives
- Responsible for providing oversight to CRO managed studies
From October 2007 to 06th July 2008: Also serving a new role of line managers for site managers (project managers) and Data managers and responsible for their performance and development to serve department and organization goals. Served both the roles of project management & line management.
From 07th July 2008 to 30th Sep 2009: Promoted as a Hub Unit Manager (Head of Clinical Operations). Role involved heading and leading the India Regional Clinical Operations organization in the implementation of the new clinical research programs and building R&D capacity.
Role profile involved the following aspects:
1. Ensure Operational Execution of the Full Developmental Programs which specifically includes the following
- Deliver on development milestones
- Identify and focus on high priority studies
2. Leverage the capacity and capabilities of CRO and Functional Service Providers
3. Maintain a high compliance through Audit, Training and quality management
4. Work closely with all stake holder which involves local stake holders such as medical affairs, regulatory department, regional medical affairs and global development operations colleagues for optimizing deployment of key studies for India and incorporate feedback into head quarter planning
5. Providing support to commercial organization which involves the following:
- Working closely with medical affairs department, commercial colleagues and ensure adequate knowledge transfer.
- Work closely to improve market access
- Providing support for India specific indications to achieve future commercial objectives
6. Foster culture of increased productivity and entrepreneurship
7. Support the ongoing development of talent including retention of key talents to deliver organization goals.
CURRENT PROFILE IN PFIZER:
1. Ensure Operational excellence in the execution of the early and full Developmental Programs
2. Maintain a highest level of compliance through Audit, Training and quality management
3. Work closely with all stake holders and customers which involves local stake holders such as medical affairs, regulatory department, regional medical affairs and global business unit colleagues for creating connectivity and strategizing clinical development for India
4. Work closely with medical affairs for ensuring relevant global study placement and assist in the launch plan for the country
5. Continuous improvement – Support the relevant improvement initiatives in line with the organization priority
6. Supporting training and development curriculum implementation for all functions in line with talent management and career philosophy
7. Resource Management- Support the resourcing in line with the business plan
8. Shape Environment -Shape Environment and commitment to Ethical Research and by implementing organization defined initiatives
9. Provide strategic and tactical support to globally outsourced projects
Project Experience
Project Description Role & Responsibilities
Phase Indication N°
Countries N° Sites & Patients
III Endocrine & Metabolism 32 (globally) 8 & 896 (out of 8500) Clinical Project Coordinator. Responsible for co-ordinating the conduct of the study and serving as protocol/training expert.
III Infectious Disease 5 (globally) 7 & 250 (out of 1100) Clinical Project Coordinator. Responsible for co-ordinating the conduct of the study and serving as protocol/training expert
II Endocrine & Metabolism 8 (globally) 4 & 32 (out of 150) Clinical Study Manager. With the responsibility for overseeing, co-ordinating the conduct of the study and full project delivery as per global Pfizer team expectations.
II Allergy & Respiratory 3 (globally) 4 & 47 (out of 112) Clinical Study Manager. With the responsibility for overseeing, co-ordinating the conduct of the study and full project delivery as per global Pfizer team expectations.
III Cardiovascular 5 (globally) 4 & 47 (out of 140) Clinical Study Manager. With the responsibility for overseeing, co-ordinating the conduct of the study and full project delivery as per global Pfizer team expectations.
III Cardiovascular 5 (globally) 3 & 20 (out of 180) Clinical Study Manager. With the responsibility for overseeing, co-ordinating the conduct of the study and full project delivery as per global Pfizer team expectations.
III Psychiatric disorder (Bipolar Mania) 20 (globally) 12 sites in India Clinical Study Manager. For this study, study starts up activities were performed till the level before Investigator’s meeting. Initial site identification, filing of application to regulatory agency (study application, import & export license), sending regulatory documents to the sites (including ICF customization, translations) and following with the sites for IRB approvals.

III Psychiatric disorder (Bipolar Mania) 10 (globally) 07 sites in India Clinical Study Manager. For this study, study starts up activities were performed till the level before Investigator’s meeting. Initial site identification, filing of application to regulatory agency (study application, import & export license), sending regulatory documents to the sites (including ICF customization, translations) and following with the sites for IRB approvals.
III Psychiatric disorder (Schizophrenia) 04 (globally) 14 sites in India
120 Patients Senior Project Manager. For this study, study start up activities were performed till the level of first patient screening.
III Psychiatric disorder (Schizophrenia) 06 (globally) 23 sites in India
200 patients Senior Project Manager. For this study, study starts up activities were performed till the level of Investigator’s meeting.

III Psychiatric disorder (Schizoaffective disorder) 06 (globally) 15 sites in India
100 patients Senior Project Manager. For this study, study starts up activities were performed till the level of Investigator’s meeting.
NA
This was a feasibility study before global study. Psychiatric disorder (Schizoaffective disorder) 04 (globally) 04 sites in India
40 patients Senior Project Manager. For this study all the activities were performed from start up to initiation, enrolment and close-outs.
III Parkinson’s Disease 08 (globally) 05 sites in India
30 patients Senior Project Manager. For this study, study starts up activities were performed till the level of Investigator’s meeting. Role was to provide oversight as a project advisor and provide support for regulatory and financial aspects.
III Parkinson’s Disease 08 (globally) 05 sites in India
30 patients Senior Project Manager. For this study, study starts up activities were performed till the level of Investigator’s meeting. Role was to provide oversight as a project advisor and provide support for regulatory and financial aspects.
III Parkinson’s Disease 08 (globally) 05 sites in India
30 patients Senior Project Manager. For this study, study starts up activities were performed till the level of Investigator’s meeting. Role was to provide oversight as a project advisor and provide support for regulatory and financial aspects.
III Immunology 20 10 sites in India, 100 patients (out of 660) Senior Site Manager. For this study, oversight was provided to CRO for start up activities. Direct responsibility for regulatory and financial activities.
II Immunology 20 6 sites in India, 30 patients (out of 170) Senior Site Manager. For this study, oversight was provided to CRO for start up activities. Direct responsibility for regulatory and financial activities.
III Cardiovascular 20 20 sites in India, 450 patients (out of 15000) Senior Site Manager. For this study, oversight was provided to CRO for start up activities. Direct responsibility for regulatory and financial activities.
III Cardiovascular 22 6 sites in India, 150 patients (out of 4022) Senior Site Manager. For this study, oversight was provided to CRO for start up activities. Direct responsibility for regulatory and financial activities.
III Cardiovascular 20 6 sites in India, 150 patients (out of 6500) Senior Site Manager. For this study, oversight was provided to CRO for start up activities. Direct responsibility for regulatory and financial activities.
III Cardiovascular 34 5 sites in India, 120 patients (out of 3060) Senior Site Manager. For this study, oversight was provided to CRO for start up activities. Direct responsibility for regulatory and financial activities.
II/III Immunology 18 7 sites in India, 40 patients (out of 300) Senior Site Manager. For this study, direct responsibility for all the project deliverables. For this study, study starts up activities are completed and study is currently enrolling.
II Oncology 16 7 sites in India, 40 patients (out of 300) Senior Site Manager. For this study, direct responsibility for all the project deliverables. For this study, study starts up activities are completed and study is currently enrolling.
III Oncology 18 8 sites in India, 40 patients (out of 512) Senior Site Manager. For this study, direct responsibility for all the project deliverables. For this study, study starts up activities are completed and study is currently enrolling.
II Oncology 7 5 sites in India, 22 patients (out of 420) Senior Site Manager. For this study, oversight was provided to CRO for start up activities. Direct responsibility for regulatory and financial activities.
Career Highlights/Achievements
- Handled/handling 25 global projects as a project manager/study manager
- Worked in therapeutic areas like infectious disease, Osteoporosis, Oncology, Psychiatry, Neurology, Cardiovascular, Immunology, Infectious disease, Allergy and Metabolic and Endocrine disorders.
- For a project handled on Osteoporosis, India was second highest enrolling country globally amongst 31 countries.
- For a project handled in the area of endocrine disorder, India was second highest enrolling country globally amongst 08 countries. Two of the Indian canters were first & second highest ranking globally in terms of enrollment. For the same study Indian centers had fastest screening rate globally.
- For a project handled in the area of Asthma, India contributed 40% of the global target. Two of the Indian centers were first & second highest ranking globally in terms of enrollment.
- For the last 5 projects/studies handled IN 2005, average Indian contribution has been 22% of the global target..
- Successfully handled 8 projects in 2006.
- Received customer care award from Quintiles Inc CEO for the performance and acknowledgement from customer.
- Operationalized working with SMOs first time in the company.
- For the first kidney transplant study in India, was able to manage critical start-up activities to support CRO for first patient first visit..
- For the three projects handled in 2007 & 2008, India was the highest and leading recruiting country globally.
- For the role as head of operation in 2008 and till middle of 2009, ensured solid project delivery wherein 25% of the projects were in the first five high enrolling globally.
- As a Head of Clinical Operations on BMS, created development plans/career path for the colleagues and created culture of accountability and performance. Ensured delivery on portfolio with highest quality.
- As a Head of Clinical Operations on Pfizer, effectively managed change with business continuity and delivery. Also implemented all the global processes and created strong line management structure with clearly defined development plans. Strongly supported and implemented new initiatives on shaping clinical research culture in India. Ensured delivery on portfolio and global metrics with highest quality.
-

Guest lecturer/Presentation at forums:
- Presented at International project specific meeting for a global study at Singapore in April 2005
- Presented as guest lecturer at KEM hospital for their undergraduates for their clinical research course
- Presented at Nair hospital for the training of their clinical pharmacology department and as a part of CDSCO training initiative for new schedule Y (Indian regulatory guideline for clinical trials).
TRAINING
- Attended Record Retention Policy Training for the department on 30 August 1999.
- Attended Financial Disclosure Project Team Training for the department on 31 August 1999.
- Passed certificate Test for CRA in June 1999. This test is a part of Pfizer Research Education.
- Passed Adverse Event Monitoring test in May 1999.
- Attended Workshop on Good Clinical Practice for the department on September 6, 7,1999 in Mumbai.
- Attended Team Building Workshop in November 1999, December 2000 & August 2001.
- Attended Workshop on Good Clinical Practice at Cochin on 20 November 1999 held for Voriconazole150-6-8 Investigators.
- Attended Time Management training in March 2000.
- Organised and participated in Workshop on Good Clinical Practice for Nizam’s Institute Hyderabad in March 2000.
- Attended Workshop on Advanced Good Clinical Practice for the department in March 2000 in Mumbai.
- Organised and participated in Workshop on Good Clinical Practice for KEM Hospital in April 2000 and for B Y L Nair Hospital in July 2000.
- Attended training programme on six hats in September 2000.
- Attended International Clinical Research Training in October 2000 at Pfizer Groton, CT, USA.
- Attended a workshop on ‘Conducting Effective Team Meetings’ on 9 October 2000 at Pfizer Groton, CT, USA.
- Attended a workshop on ‘Performance Management’ on 10 October 2000 at Pfizer Groton, CT, USA.
- Attended a training programme on field monitoring between 30 October 2000- 2 November 2000 at Seattle, Washington, USA.
- Attended a ‘Creativity Workshop’ between 16 January- 21 January 2001 at Karjat.
- Completed the specialised Master Orator Course in ‘ Successful Public Speaking’ held from February 2001 to March 2001.
- Attended a workshop on “Cross cultural sensitivity” in August 2001.
- Attended a workshop on communication (writing) skills in August 2001.
- Attended a workshop on Effective communication skills in October 2001.
- Personal Effectiveness and Team Working Skills workshop in December 2001.
- Attended a workshop on Road to World Class Quality, Problem Solving & Creativity Tools in November 2002.
- Attended a workshop on Excellence in Service Quality in December 2002.
- Attended training on Negotiation Skills in July 2004.
- Attended training on Leading Edge- Development of leadership, program conducted by Pfizer India leadership team in April 2005.
- Attended Schedule Y- The New Look conducted by Indian Drug Manufacturers Association [Mumbai, 27 August 2005].
- Attended training on coaching skills conducted by Pfizer experts on 24th November 2005.
- Attended training on Performance Management Principle (PMP) and Coaching for High Performance (CHP) from 16 – 18 May, 2007 in Bangkok, Thailand.
- Attended training on communication skills in July 2007.
- Attended training on New Line manager training on 10th March 2008..
- Attended training on Innovation on 16th July 2009
- Attended training on Continuous Improvement in 2009
- Attended training on Advanced Managerial & Leadership Development Program in August 2010
- Attended training on Managerial Effectiveness in May 2011
Project Management specific training:
- Attended a workshop on ‘Project Management’ on 11October 2000 at Pfizer Groton, CT, USA.
- Attended a training programme on ‘FDA/Industry Project Management in Drug Development & Review’ held between 23-25 October 2000, organised by Pharmaceutical Education & Research Institute at Bethesda, MD, USA.
- Passed certificate Test for Clinical Research Manager in January 2004. This test is a part of Pfizer Research Education.
- Attended training in Project management for Clinical Research Professionals in May 2004 conducted by external UK based faculty.
- Attended training workshop on Clinical Research Project Management, conducted by IBC Asia Pte Ltd in Singapore from 28-29 September 2005.
- Attended training workshop on managing by project, conducted by Quintiles in Bangalore in February 2005.
- Attended training workshop on leading for performance conducted by Quintiles in Bangalore in May 2005.
- Attended training on Project Management Framework during the 3 days workshop at BRISTOL-MYERS SQUIBB, Wallingford, USA in November 2006.
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Submission ID : 4350894
Date & Time : 9th Jul 2011 1:31 PM (UTC)
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