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Clinical Trails Project Manager

Location
City, York
Salary
£38,000 to £42,000
Job Type
Permanent
Posted
20 Jul 2022
As a member of my clients Clinical Trials Project Management team, the Project Manager Clinical Trials is
accountable to deliver assigned studies with quality, on time, on budget, and as contracted. Serves as
friendly, engaging and responsive primary point of contact for clients; works collaboratively with CT
clients, Set Up Project Manager and key stakeholders from study award through study closure sign off
from client. The Project Manager supports complex, critical and large scale Clinical Trials, and serves as a
mentor to other members of the team
Key Responsibilities:
Guarantee client satisfaction by providing exceptional service through a consistent customer centric approach, focus on precision delivery and flexibility to meet customer expectations.
Maintain positive working relationships with CT clients, Business Development Directors,
Clinical Trials Study Management and key stakeholders
Manage multiple complex, multi region and multiple clinical trials studies at one time.
Evaluates and communicates monthly project metrics and analyses all activity related to the trial, including monthly budget review.
Collaborates with Medical Writer to produce the Global Laboratory Specification Document
(GLSD), Investigator Manual, and protocol specific Global Work Practice Instructions.
Manage all aspects of client project management needs including: partnering with the Study
Set Up team to successfully launch a study, serve as a point of contact throughout the study and see studies to a positive closure.
Identify and resolve issues/requests in a timely manner per service and metric guidelines; following Standard Operating Procedures for escalations, change control and communication.
Deliver accurate and timely study data during execution by reviewing, approving, and
communicating to the client study budget (study bid to bill), study metrics, study amendments,
Note to File, study issues, general study status, and by attending client audits
Perform successful study closure by proactively preparing for last patient, last visit (LPLV),
communicating and working with the study support teams to address outstanding issues, and working with the client on timelines and plan for study closure based on agreed timelines.
Participates in Quality Audits and inspections of Clinical Trials as prescribed by departmental policies and regulatory agencies.
Maintain a general working knowledge of Food & Drug Administration (FDA), Medical & Healthcare
Regulatory Agency (MHRA), New York State Department of Health (NYSDOH), Good Clinical
Practice (GCP), ICH and other pertinent regulations.
Actively participates in process improvement within the Clinical Trials Project Management team
by developing methods to improve productivity, service, quality, cost savings, policies & procedures.
Participates in Clinical Trial Study Management meetings and task forces to develop
standardisation in the set up process across protocols and departments.
Aids in the development of Standard Operating Procedures and associated training.
Demonstrates initiative in professional self-development to improve job performance to maintain relevant working knowledge of Clinical Trials.
Acts as a mentor to Clinical Trials Study Management team, including but not limited to Project Managers, Associate Project Managers and Project Coordinators.
Manages ad-hoc process improvement/remediation projects as required Perform other duties as
assigned.

MINIMUM QUALIFICATIONS:
Bachelor s Degree required.
2 years of clinical trials project/study management experience.
Excellent interpersonal, organization and management skills
JOB POSTING - PROJECT MANAGER CT:
Summary
This is an amazing opportunity for a proven Project Manager from a Clinical Trials background to step up
and oversee various studies and trials that will push their knowledge and understanding to the next level.
As a member of our Clinical Trials Project Management team, the Project Manager is accountable to
deliver assigned studies with quality, on time, on budget, and as contracted. Serves as friendly, engaging
and responsive primary point of contact for clients and works collaboratively with CT clients.
STATUS: Full Time
LOCATION: York, UK
SCHEDULE: Monday - Friday; Days
ATTRIBUTES:
Bachelor s Degree required.
2 years of clinical trials project/study management experience.
Excellent interpersonal, organization and management skills
KEY RESPONSIBILITIES:
Customer Service. Act as client's primary point of contact; maintain a high level of customer
service and satisfaction; display precision in delivery and flexibility in approach; assume full responsibility for study conduct, ensuring client goals and timelines are met; perform troubleshooting and problem-solving functions as needed
Study Management. Manage 10 to 20 studies, depending on scope and complexity; review
clinical protocols and assist with study set-up functions as required; develop the Global

Laboratory Specification Document, Investigator Manual and protocol-specific Global Work
Practice Instructions; develop protocol specific procedures as needed
Evaluation & Training. Evaluate and communicate monthly project metrics and analyses of all
activity related to the trial, including monthly budget review; conduct investigator training
sessions by telephone or at investigator meetings.
Documentation Management. Assume responsibility for required study documentation and
comply with standard procedures for collecting, maintaining and archiving materials in
accordance with regulations and policies
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Details

  • Job Reference: 662717597-2
  • Date Posted: 20 July 2022
  • Recruiter: FCL Recruitment
    FCL Recruitment
  • Location: City, York
  • Salary: £38,000 to £42,000
  • Sector: Healthcare & Medical
  • Job Type: Permanent