Walkin Interview in Quintiles on 13th June 2015 @ Quintiles
Job Description
Exclusive walkin interview in Quintiles -Bangalore Location on 13th June 2015.
Job Location: Bangalore
Exp:
Skill : Regulatory start UP, Feasibility
Mumbai Venue details
Quintiles Research (India) Private Limited
Quintiles Technologies India Pvt. Ltd.
Prestige Technology Park II,
Etamin Block, Ground Floor, A Wing
Sarjapur-Marathalli Outer Ring Road,
Bangalore 560103
Contact Person: Shashikala
Registration Time : 8.00AM
Title: Regulatory Start UP , Feasibility Specialist
Roles & Responsibilities
PURPOSE
Direct and manage the delivery of all required start-up, maintenance and regulatory activities for selected studies as determined by either the agreed algorithm or the Sponsors requirements, including pre-award activities, oversight of the scope of work, budget and resources.
RESPONSIBILITIES
The role holder may be required to cover all or some of the responsibilities mentioned below but will focus on selected activities at any one time, depending business requirements.
Oversee the execution of Start Up (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU strategy.
Develop, implement and maintain the RSU Management Plan in accordance with the Scope of Work and Project Plan, within the agreed project strategy.
Ensure collaboration across RSU, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
Assist with creation and/or review of core scientific, technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
Contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required.
Work with Quality Management to ensure appropriate quality standards for the duration of the project.
Mentor and coach colleagues as required.
Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information
May take a proactive role in developing long standing relationships with preferred Quintiles customers.
Deliver presentations/training to clients, colleagues and professional bodies, as required.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Good negotiating and communication skills with ability to challenge
Good interpersonal skills, a strong team player
Experience in regulatory and/or technical writing
Good understanding of regulated clinical trial environment and knowledge of drug development process
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
Ability to exercise independent judgment taking calculated risks when making decisions
Good leadership skills, with ability to motivate, coach and mentor
Good organizational and planning skills
Good presentation skills
Good understanding of study financial management
Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
Kind Regards,
Shashikala
HR Staffing - India
Salary: 1,50,000 - 4,75,000 P.A
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Role Category:R&D
Role:Clinical Research Associate/Scientist
Keyskills
Site Selection
Clinical Research
CRF
Site Management
feasibility
Regulatory
Desired Candidate Profile
Education-
UG: Any Graduate - Any Specialization, Graduation Not Required
PG:Any Postgraduate - Any Specialization, Post Graduation Not Required
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required
Click here to apply
Job Description
Exclusive walkin interview in Quintiles -Bangalore Location on 13th June 2015.
Job Location: Bangalore
Exp:
Skill : Regulatory start UP, Feasibility
Mumbai Venue details
Quintiles Research (India) Private Limited
Quintiles Technologies India Pvt. Ltd.
Prestige Technology Park II,
Etamin Block, Ground Floor, A Wing
Sarjapur-Marathalli Outer Ring Road,
Bangalore 560103
Contact Person: Shashikala
Registration Time : 8.00AM
Title: Regulatory Start UP , Feasibility Specialist
Roles & Responsibilities
PURPOSE
Direct and manage the delivery of all required start-up, maintenance and regulatory activities for selected studies as determined by either the agreed algorithm or the Sponsors requirements, including pre-award activities, oversight of the scope of work, budget and resources.
RESPONSIBILITIES
The role holder may be required to cover all or some of the responsibilities mentioned below but will focus on selected activities at any one time, depending business requirements.
Oversee the execution of Start Up (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU strategy.
Develop, implement and maintain the RSU Management Plan in accordance with the Scope of Work and Project Plan, within the agreed project strategy.
Ensure collaboration across RSU, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
Assist with creation and/or review of core scientific, technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
Contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required.
Work with Quality Management to ensure appropriate quality standards for the duration of the project.
Mentor and coach colleagues as required.
Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information
May take a proactive role in developing long standing relationships with preferred Quintiles customers.
Deliver presentations/training to clients, colleagues and professional bodies, as required.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Good negotiating and communication skills with ability to challenge
Good interpersonal skills, a strong team player
Experience in regulatory and/or technical writing
Good understanding of regulated clinical trial environment and knowledge of drug development process
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
Ability to exercise independent judgment taking calculated risks when making decisions
Good leadership skills, with ability to motivate, coach and mentor
Good organizational and planning skills
Good presentation skills
Good understanding of study financial management
Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
Kind Regards,
Shashikala
HR Staffing - India
Salary: 1,50,000 - 4,75,000 P.A
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Role Category:R&D
Role:Clinical Research Associate/Scientist
Keyskills
Site Selection
Clinical Research
CRF
Site Management
feasibility
Regulatory
Desired Candidate Profile
Education-
UG: Any Graduate - Any Specialization, Graduation Not Required
PG:Any Postgraduate - Any Specialization, Post Graduation Not Required
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required
Click here to apply
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