Covance

Clinical Project Manager - CPS (Phase I clinical trials)

Job Location(s) AU-Sydney | AU-Melbourne | AU-Brisbane | AU-Adelaide
Job Number
2020-54244
Job Category
Clinical Pharmacology
Position Type
Full-Time
Telecommute
Yes

Job Overview

Experience a powerful partnership
Are you someone that loves to share creative strategies and help project teams move ahead? Could you handle a project’s immediate issues without losing sight of the big picture? Do you enjoy problem solving and setting up teams for success?
 
Join Covance as a Clinical Project Manager. In this role, you will:
 
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Manage scope of project and project components, budgets, timelines, and quality guidelines

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Ensure that expectations are met while identifying and mitigating risks. 

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Responsible for managing the project team in a matrix environment.

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Contribute to strategic relationships by monitoring and reporting Key Performance Indicators (KPI), and may assist in the development of KPI. 

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May lead bid defense and other business development activities.

Why project managers choose Covance
At any company, clinical project managers are faced with deadlines and deliverables. As a Covance Project Manager, you can expect to:
 
- Build a long-term career path as you join a PM team where more than 50% have been growing in Covance’s positive culture for 5 or more years
- Develop your career as you participate in industry-leading training and mentoring
- Gain exposure to studies across early clinical development to late stage trials – and explore new opportunities across outside business units
- Work with top-notch people as you serve as a valuable partner to clinical sites
- Receive ongoing support from our project teams and Clinical Trial Management Office that deliver additional resources needed to get your work done while helping you create balance across all important areas of your life
What we’re looking for
If you are an exceptional person that has experience acting as a Project Manager for at least 1 year, has overseen phase I Oncology trials in Australia and has knowledge in first in human study design we want to hear from you.
Other essential requirements include:
- Works independently to lead a project team or under the direction of a more senior Project Manager on a program of studies, while adhering to professional, SOP, regulatory and ICH/GCP standards.
- Assesses resource needs for project or program delivery based on scope of services to be provided.
- Manages and communicates scope of the project according to proposal, budget, timeline throughout the life cycle of the project. Works with project team on identification of work scope changes against the project timelines.  Creates and/or review required project plans. Implement and monitor progress against project.
- Plans and timelines and revise as necessary. Ensure consistency of plans across programs.
- Organizes, chairs, and ensures accurate documentation in meeting minutes for project meetings with client and team, as applicable. Completes, or delegates with oversight, the Project Log (Action/Decision/Issues) items to ensure appropriate project team member delegation and resolution.
- Performs overall management of the project timelines through use of MS Project ensuring that changes or updates are made and communicated in a timely manner. Renegotiates timelines with client and project team as necessary.
- Develop a thorough understanding of clinical, biometrics and critical path activities.
- Proactively engages in both quality assurance and risk management and mitigation activities to ensure project deliverables are met according to both Covance and client requirements, ensuring appropriate escalation of risks to all stakeholders.
- Manages and communicates scope of the project according to proposals, budgets and ongoing project progress. Works with project team in identifying, initiating work scope changes, tracking and delivering to the client.
- Responsible for the review and assessment of ongoing hour/budget utilization throughout the course of project to ensure that the projects are meeting financial targets.
- Supports negotiations with client to ensure budget remains within contracted terms. Controls project margins and minimizes write offs by working with key stake holders and senior leadership.
- Collaborates with finance when project milestones or completion of contracted units of activity have been met to approve monthly invoicing, and performs client follow up as appropriate.
- Accountable for TMFs including TMF Index & Plan, audit readiness and delivery of the TMF per agreed upon timelines, when contracted by client.
- May oversee timely uploading of documents by the project team into the TMF for client held systems.
- Accountable for directing the CTMS build, working with project team to ensure loading of information for site activation and timely entry of key milestones for site payment.
- Accountable for developing Project Specific Training and ensuring project team members have read, reviewed and documented project related documents and plans.
- Drives issue resolution at the project and program level. Ensures proper escalation of potential CQI per Covance SOPs.
- Contributes to audit responses from agencies and clients, as appropriate.
- Ensures lessons learned are implemented across projects currently being managed and across the department as applicable.
- Initiates and drives improvements to enhance the efficiency and the quality of the work performed on assigned projects.
- Assist in the reporting of strategic client metrics.
- Contributes to proposal strategy, development, and lead bid defense strategy for assigned business development opportunities.
- May perform supervisory duties including, but not limited to, interviewing, hiring, training, developing, performance evaluation, intervention, discipline, and discharge for Project Managers.
- Increase potential for repeat business by establishing a strong working relationship with the client project team striving for client satisfaction and operational excellence.
See what Covance project managers have to say
“I continue to be amazed at the great things we are able to do here at Covance. Staff are selfless and willing to do whatever is necessary to ensure success."
"I am given a great deal of opportunity to contribute to the decision process and voice concerns and suggestions."
The PM opportunity
Beyond compensation and the comprehensive benefit package you'll receive as a Clinical Project Manager, joining Covance opens the door to many career opportunities. Learn about what’s possible for your career when a company truly invests in you at http://careers.covance.com/possibilities.html
Get to know Covance
Here, you'll own your career, make an impact and be a part of a leading company that has supported development of 50 out of the top 50 prescription drugs in the market. Empowered by our LabCorp partnership and data for more than 70 million patients, we can offer clients a complete set of end-to-end clinical trial solutions aligned to global therapeutic needs. In return, you’ll be empowered in a flexible team environment with mentoring and training to get the most out of your career.
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

Education/Qualifications

Education/Qualifications/Certifications and Licenses:
 
Recommended:
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.
Acceptable: In lieu of the above requirement, candidates with a 2-year Associate Degree and additional 5 or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
 
Preferred:
Cetiified  in Clinical Research - PMP,  SOCRA/ACRP  Certification
Masters or other advanced degree.

Experience

Experience: Minimum Required:
- Minimum of 5 years' relevant clinical research experience in a pharmaceutical company/CRO including demonstrated skills and competency in project management tasks.
Acceptable: In lieu of above experience requirement, a combination of other experiences including, but not limited to preclinical research, biometrics clinical supervision, clinical study management, clinical monitoring, and clinical project management may be considered.
- Experience in managing projects in a vittual environment.
- Demonstrated ability to handle multiple competing priorities and to utilize resources effectively.
- Financial awareness and ability to track project progress against financial milestones.
- 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.
- 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 software packages.
- Detailed knowledge of project management processes.

Preferred:
- Working knowledge of Covance with cross functional depaitment expertise.
- Basic knowledge of Covance sales and business development strategies and procedures.
- Working knowledge of Covance SOPs.

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