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Clinical Research Project Manager – Phase 1

  • Anywhere

Company :
Covance by Labcorp

Location :
Madison, Wisconsin

Expiry Date :
Sun, 25 Apr 2021 23:59:59 GMT

Apply Job :
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Description :
JOB OVERVIEW:

Oversees and manages domestic, regional and/or international clinical trials conducted at
Covance Clinical research sites, external sites, and data services projects. Projects generally
include full service including multiple moderately complex trials managing multiple vendors and
external sites for trials of moderate to high financial value, and may consist of serving in a
program oversight role. Primary client contact and responsible for the facilitation of
communication, managing client expectations, and building business relationship.

* Responsibilities typically include managing scope of project and project components, budgets,
timelines, and quality guidelines thereby ensuring that expectations are met while identifying and
mitigating risks.
* Responsible for managing the project team in a matrix environment.May also contribute to strategic relationships by monitoring and reporting Key PerformanceIndicators (KPI), and may assist in the development of KPI. Using detailed knowledge of clinicaldevelopment, may lead bid defense and other business development activities.
* 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.
* 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.
* 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.
* 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.
* Controls project margins and minimizes write offs by working with key stake holders and seniorleadership.
* Oversees the coordination of the study activation components of the project from an oversight level including Feasibility, Site selection, Activation, Site Contracting, Regulatory Submission, Greenlight.
* Assists in the design and maintenance of tools/ processes relevant to feasibility assessments and patient recruitment campaigns.
* Supervision of Investigator package review and approval prior to drug shipment.
* Supervision of study set-up with the clients regarding pre-study documentation for Investigator packages.
* Supervision of Site Budget and Statements of Agreement (SoA) documents that leads to an executed site contract.
* Supervision of Document Review, including Informed Consent Forms, labels and protocols.
* Perform other duties as assigned by management.
*

EDUCATION/QUALIFICATIONS:

Recommended:

* University/college degree (life science preferred) or ce1iification 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 Cetiification
Masters or other advanced degree.

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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