Senior Project Manager - Clinical Pharmacology Services
Posted on: June 15, 2019
Job Overview As a Senior Project Manager for our Clinical
Pharmacology Services team you will oversee and manage 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 high financial value, and may consist of
serving in a program oversight role. Key Responsibilities:
- The Project Manager will be the primary client contact and
responsible for the facilitation of communication, managing client
expectations, and building business relationships.
- Managing scope of project and project components, budgets,
timelines, and quality guidelines thereby ensuring that
expectations are met while identifying and mitigating risks.
- May be responsible for managing the project team and mentoring
others in a matrix environment.
- Contribute to strategic relationships by monitoring and
reporting Key Performance Indicators (KPI), and may initiate
process improvements to address variance, and may serve as a
committee member on a governance structure.
- Using thorough knowledge of clinical development, the Senior
Project Manager may design delivery strategy for large scale bid
defense and performs other business development activities.
- May act as a single point of contract for the client 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 program or 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 program or project timelines. Creates
and/or review required project plans. Implement and monitor
progress against project
- Organizes, chairs, and ensures accurate documentation in
meeting minutes for program or 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 program or 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.
- Has extensive understanding of complex clinical, external site
management, biometrics and critical path activities.
- Supports negotiations with client to ensure budget remains
within contracted terms. Improves project and program margins based
on project financial expertise and minimizes write offs.
- Proactively engages in development of project and or department
quality assurance and risk mitigation activities that is cost
effective and obtain agreement with client and key
- 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.
- Serves as the escalation point for project uses and resolve
conflicts as necessary
- 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
- Ensures lessons learned are implemented across projects
currently being managed and across the department as
- Attend Triage meeting as required
- Increase potential for repeat business by establishing a strong
working relationship with client project team striving for client
satisfaction and operational excellence
- Contributes to proposal strategy, development, and lead bid
defense strategy for assigned business development
- May own a relationship with key strategic clients(s) with
development and implementation of partnership plans, processes,
tool and templates
- Leads implementation of process excellence initiatives on
projects and across department that enhance the efficiency and the
quality of the work performed on a program or project.
- Develop strategic client metrics and track project metrics
across program as needed. Monitor and report KPI for strategic
relationships, actively managing to ensure they are within the
scope of the contract and initiate process improvements to address
- May serve as a committee member in a governance structure for
strategic clients (use for leveling
- Assists training and development of more junior and project
- Develops or is a SME contributor to department training
- Perform other duties as assigned by management. Site Management
- Responsible for the oversight of site start up activities.
- Oversees the coordination of the study activation components of
the project from an oversight level including Feasibility, Site
selection, Activation, Site Contracting, Label/Supply, Regulatory
- Assists in the design and maintenance of tools/ processes
relevant to feasibility assessments and patient recruitment
- 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, Advertisements, labels and protocols.
- 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
- In lieu of the above requirement, candidates with a two (2)
year Associate Degree and additional five (5) or more years of
relevant clinical research experience in pharmaceutical, CRO
industries or experience in a health care setting will be
- Certified in Clinical Research - PMP, SOCRA/ACRP
- Masters or other advanced degree
- PMP Certification
- Six Sigma trained Experience Minimum Work Experience:
- Minimum of seven (7) 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, clinical biometrics, clinical study
management, clinical monitoring, and clinical project management
may be considered.
- Experience in managing projects in a virtual 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
- Ability to work independently.
- Ability to negotiate and liaise with clients in a professional
- Ability to present to staff at all levels.
- Good computer skills with good working knowledge of a range of
- Detailed knowledge of project management processes. Preferred:
- Working knowledge of Covance with cross functional department
- Basic knowledge of Covance sales and business development
strategies and procedures.Working knowledge of Covance SOPs
Keywords: Covance, Madison , Senior Project Manager - Clinical Pharmacology Services, Healthcare , Madison, Wisconsin
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