Covance

Project Manager, Start-Up

Job Location(s) AU | KR | IN
Job Number
2020-52270
Job Category
Clinical Study Start Up
Position Type
Full-Time
Telecommute
Yes

Job Overview

Job Overview
 
Covance has an opening in the Start Up Project Management team.  This role will oversee and manage the study start up and maintenance activities of regional / global clinical trials.  This role can be carried out remotely and our preferred locations include Australia, Korea and India.
 
Responsibilities:
 
As a Start Up Project Manager you will: 
 
- Lead start-up and maintenance team during study start-up and maintenance phase liaising directly with Project Lead, core team members and the client, as applicable.
- Work with cross functional project team and external teams ensuring effective communication, collaboration and teamwork to achieve study objectives and milestones
- Serve as primary client contact, developing and building strong relationships and contributing to meeting / exceeding client satisfaction expectations
- Manage appropriate project resource and lead the core project team to achieve study objectives and milestones
- Assist in the design, implementation, tracking and revision of project plans for assigned studies
- Identify, assess and mitigate study risks
- Track study progress against financial milestones
- Oversee finalisation and distribution of critical study documents for submission (including translations)
- Support budget negotiation, contract escalations and queries with the local team and the client
- Assist in ensuring country specific laws and regulations as well as internal SOPs and processes are followed on your assigned studies
- Support regulatory authority and client inspections, managing any audit findings to their resolution
- Provide performance feedback of team members to respective supervisors
- Support study proposal and bid defence activity, as required 
Requirements:
 
- Minimum of four to six (4-6) years relevant clinical research experience
- Knowledge of financial control procedures (e.g. costing systems, time reporting)
- knowledge of project management processes, especially regarding study start-up
- Excellent organizational and time management skills
- Working knowledge of ICH-GCP, regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred
- Excellent communication skills, oral and written
- Flexibility to attend global meetings

Education/Qualifications

Required:
♦University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
♦ Working knowledge of financial control procedures (e.g. costing systems, time reporting).
♦ Working knowledge of project management processes, especially regarding study start-up.
♦ Working knowledge of time and cost estimate development.
♦ Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
♦ Broad knowledge of drug development process and client needs.
 
Preferred:
♦Masters or other advanced degree.
♦ PMP certification.
♦ Working knowledge of Covance and the overall structure of the organization.
♦ Working knowledge of Covance sales and business development strategies and procedures.
♦ Working knowledge of Covance SOPs.
 

Experience

 
♦Six (6) or more years of drug development and clinical research experience (pharmaceutical, biotech or CRO), preferably including three (3) or more years project management responsibility / leading clinical trials in Study Start-up.
♦ Experience in managing global projects with moderate financial value.
♦ Demonstrated ability to handle multiple competing priorities.
♦ Ability to utilize resources effectively on moderate scope projects.
♦ Financial awareness and ability to actively manage financial tracking systems including moderate projects
♦ Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.
♦ Demonstrated ability to lead by example and to encourage team members to seek solutions.
♦ Experience mentoring junior level staff.
♦ Excellent communication, planning and organizational skills.
♦ Ability to work independently.
♦ Ability to negotiate and liaise with clients in a professional manner.
♦ Ability to present to staff at all levels.
♦ Good computer skills with good working knowledge of a range of computer packages.
 

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