Project Manager Management
Resume:
Dr. Surendra Raju. R
Position: Associate Project Manager
Summary
Having 5+ years of experience in Clinical Research as Clinical Research Associate, Clinical Team Leader & Associate Project Manager involved in clinical trial monitoring and project management.
Currently managing 2 Phase III, Global, IVF & Diabetes studies as Project Manager. Managing a team of CRA’s, CTA’s in India and Middle East Countries (Lebanon, Jordan, Iran, Saudi Arabia and UAE).
• During my tenure in ClinTec as Clinical Team Leader & Associate Project Manager, I was given an opportunity to function as a lead project manager for Phase IV, Global study involving 5 Middle East countries and 554 Investigators.
• Also I was involved in the study planning phase for Phase IV, Global study Involving 3 countries. Actively participated in protocol development, CRF development and other study related documents.
• Have been involved in project budgeting, bid-defence meetings and feasibility. I have accompanied senior directors and senior business development executives for Face to Face International bid defence meetings.
• Have Organised Investigators Meeting in India and abroad for the studies, which I am currently involved.
As Clinical Research Associate, I have assisted in monitoring activities across Cardiology trial in Atrial Fibrillation, Neurology trial in Parkinson’s disease and in a trial on Deep Vein thrombosis.
As Clinical Research Associate, I have managed Phase III, global, Diabetes, Oncology and Acute coronary syndrome, wherein span of my duties on these trial involves coordinating translation of study documents, ethics committee and regulatory submissions, in-house maintenance of study documents, management of clinical trial supplies, preparation of IP release packets, Site selection, Site Initiation & On-Site monitoring, coordinating for data base lock & Site close out visits, etc.
• Have taken up a challenging work model; in this model have worked with various global sponsor companies.
• Have taken an overall responsibility of guiding a huge team of Investigators for a global investigators meeting.
• Have developed good relationship with the key investigators
• Have been instrumental in coordinating with the Data Management team and all sites for query resolution, completing data entry and have ensured to accomplish all the targets and timelines set for the study
• Have experience in monitoring high recruiting site and have implemented recruitment strategies to enable sites to achieve recruitment target well within the timelines despite regulatory delays encountered.
• Have experience in managing the “Clinical Trial Supplies” to various sites across India.
• Have been proactively analysed the potential risks of the study supplies and managed it effectively, without compromising the study timelines and deliverables.
Responsibilities are summarised below
Feasibilities Initiation visits Audits
Attendance to Investigator Meetings Monitoring visits & SDV Inspections
Delivery of GCP training’s Closure visits Submission dossier
Submissions to Regulatory body Query resolution Collection of regulatory packages
Submissions to Ethic committees Drug accountability
Site Selection visits Management of SAEs Re-labelling process
Education / Qualifications
Date Place of Education Qualifications
July 2007 Manipal University P G Diploma in Clinical Research & Data Management
April 2005 M R Ambedkar Dental College & Hospital. Bachelor of Dental Surgery
(Rajiv Gandhi University Of Health Sciences)
Employment History
Employer/From – To Roles & Responsibilities
ClinTec (India) International Pvt. Ltd
23rd Septemeber 2010 to
till date Designation: Associate Project Manager
Since Oct 2011 to till date.
Designation: Clinical Team leader
Since 23rd Sep 2010 to Oct 2011.
• Currently managing and co-coordinating with cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
• Managing phase 3 studies in India, Middle East and Asia Pacific region.
• Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.
• Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to.
• Lead problem solving and resolution efforts to include management of risk, contingencies and issues.
• Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.
• Provide input for the development of proposals for new work and manage project budgets.
• Prepare and present project information at internal and external meetings.
• Participate in proposal development and in the bid-defense process with guidance and supervision.
• Ensure high performance and efficiency of the clinical team through co-monitoring /accompanied site visits.
Quintiles Research( India) Private Ltd
09th July 2007 to
22nd September 2010. Designation: Clinical Research Associate II
Worked on FSP(Large Scale Functional Resourcing) model
For Johnson & Johnson India Ltd
Since 01-Mar-2009 till 22nd September 2010.
Worked on FSP(Large Scale Functional Resourcing) model
For AstraZeneca Pharma India Ltd
Since 1st April-2008 till 28-Feb-2010.
Worked on Quintiles Core Projects
Since 09th July 2007 till 1st April 2008.
Responsibilities:
• Responsible for Project start up processes, study communication, site selection, site initiation, site monitoring, in compliance with the ICH-GCP and relevant SOPs in close coordination with the Sponsor
• Responsible to attain clinical deliverables within study timelines and budget by setting up clinical tools and processes for the study team
• Site Selection:
o Identifying potential investigators and performing Site Selection Visits and document the same
o Contact and visit potential investigators
o Ensure adequacy of clinical research staff/facilities with regard to agreed (Quintile’s or Sponsor’s) SOPs, GCP, and appropriate regulatory requirements.
o Identify issues and arrange for resolutions by lead CRA/Clinical team Leader/Project Manager.
o Assure that site teams are aware of protocol and protocol related documents.
o Document the site selection visit
• Study initiation:
o Conduct site initiation visits and document the same
o To compile Ethics Committee submission documents, Co-ordinate shipment of study-related materials and Investigational Product to sites
o Assist in IM preparation and attend investigator
• On-Site Monitoring:
o Assure investigator’s adherence to protocol and GCP and initiates actions to resolve issues.
o Assure regulatory documents are available and current, review AEs, SAEs and Data Clarification Form (DCFs)
o Perform source document verification and review CRFs as agreed in the contract.
o Perform Investigation Product and other study related material accountability and review condition of medication/containers and storage
• In-house Monitoring:
o Prepare trip reports, recommending corrective action where appropriate.
o Maintain regular telephone contact with site and documents the same.
o Maintain study-specific tracking files and databases and ensures that they are current.
o Coordinate with Sponsor Global Team on regular basis and update the global and regional study personnel’s fully appraised of site and study status
o Lead the regional CRA team and delegate, coordinate task to achieve study deadlines.
o Identifying training needs for study team (Site staff) and training them on the study aspects and processes.
• Study Termination:
o Resolve outstanding DCFs and Retrieve CRFs.
o Ensure regulatory documents are available and current.
o Ensure Clinical Trial Material (CTM) accountability and CTM return and disposal.
o Conduct site closure visits as directed by CTL/PM/sponsor and archival of study documents
• Perform administrative duties including attendance at clinical monitoring staff meetings, project team meetings, clinical training sessions, etc.
• Identify and record quality issues.
• Suggest, initiate, recommend and/or provide solutions as appropriate
• Perform other study related tasks as assigned by superiors
• Correspondence with the sites & third parties
• Translation of study documents.
Multi-Speciality Dental Clinic
May 2005 to July 2007
Designation: Dental Surgeon
Responsibilities:
• Diagnosis
• Treatment Planning
• Aesthetic restorations
• Smile designing
• Prosthodontic Correction of Teeth
• Conservative & Full Mouth Rehabilitation
• Minor-Orthodontic correction of Teeth
• Specialised in Root Canal Therapy & Conservative Rehabilitation
• Trained on CAD CAM prosthesis.
• Trained on Preventive orthodontic therapies targeted for young patients.
• Have assisted in Major and Minor OT procedures pertaining to maxillofacial region.
Project Experience as Clinical Team Leader & Ass Project Manager
Project Description
Phase Indication and Drug Class Number of Countries Number of Sites & Patients Description of Responsibilities/Tasks
Including start and end dates
Phase III Global Study In-vitro Fertilization
Lebanon
Jordan
Iran
KSA
UAE
Egypt 6 sites
208Patients
Project Manager
Phase III Global Study Diabetes Type II.
India
80 Patients
11 sites
Project Manager.
Phase IV
Global Study Genital Warts Bahrain,
Oman,
Qatar,
KSA,
UAE. 277 Investigators
1400 Patients
Lead Project Manager during Initial Phase of the study
Phase IV
Global Study Rheumatoid Arthritis Middle East Countries NA Study Planning Phase, Development of Protocol and CRFs.
Project Experience as Clinical Research Associate
Project Description
Phase Indication and Drug Class Number of Countries Number of Sites & Patients Description of Responsibilities/Tasks
Including start and end dates
Phase IV
Global Study Diabetes Type II.
India
300 sites
1500 Patients Involved in Monitoring the CRF pages for the quality control of the Data generated from the sites.
Phase III
Global Study Diabetes Type II.
India
Europe 500 Patients
10 sites in India Co-Monitoring with the Lead CRA to meet the project deadline.
Phase III
Global Study Diabetes Type II.
India
Philippines
Korea
China 150 Patients & 7 sites from India
Lead CRA handled project from start up, IM, SIV, SMV, DB lock, SCV and archival
Phase III
Global Study Diabetes Type II.
India
Philippines
China 155 Patients & 6 sites from India Lead CRA handled project from start up, IM, SIV, SMV, DB lock, SCV and archival
Phase III
Global Study ACS
Cardiovascular Multi National 1800 Patients Involved in SSV, SIV & SMV
Phase III
Global Study NHL
Oncology Multi National 500 Patients Involved in Monitoring, DB lock and site close out visits.
Systems Experience/IT Skills
PC Skills
• InnTrax (Clinical Trial Management System)
• Impact
• Medidata Rave,
• Oracle RDC
• IVRS/IWRS/IXRS
• Informatics, CTMS, Beacon,
Membership of Professional Associations
• Karnataka State Dental Council
• Member of International Biopharmaceutical Association (IBPA)
• Indian Dental Association (IDA)
Publications
• Presented a scientific paper on “Chlorhexidine in Endodontics” at South India Dental Conference, Cochin
• Conducted Survey on Incidence of Dental Caries in slum dwellers & school children.
• Conducted Survey on Waste Disposal & Management in dentals clinics. (Mercury toxicity).
• Founder & Editor in Chief for “Fenetre” an international journal on Dental Advances.
Other Relevant Details
Languages known –
• English: Fluent, Medium of Education
• Kannada: Fluent
• Hindi: Fluent
• Telugu: Fluent, Mother Tongue
Personal Details
Father’s name : Mr. RANGA RAJU.P
Date of birth : 07th May 1981
Nationality : Indian
Marital Status : Married
Languages known : English, Kannada, Telugu, Hindi.
Address : #12, Sanjeeva Naik Lane
Avenue road cross,
Bangalore-560002, INDIA
Mobile : +91-988**-*****
E-mail : *************@*****.***
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