Clinical Study Manager

Clinical Study Manager

Biotechnology Clinical Life Sciences Pharmaceuticals

Location Newcastle-upon-Tyne

Salary Competitive

Contract Permanent

Reference PCclstmg7

Date Posted

Consultant


An unique opening for a Clinical Study Manager has become available with a growing organisation involved in the exciting area of IVD Technology.

As Clinical Study Manager you’ll be responsible for managing multiple studies, including the planning, implementation, oversight, project management and completion of clinical studies conducted by internal and its contractors. This role serves as the project lead for studies of moderate to high complexity from protocol development through study conduct and closeout in compliance with GLP, IVDR, and all Global, National and Local Regulations.

As project Lead, you’ll be reviewing needs of stakeholders, aligning to requirements and designing and implementing a system for effective management and coordination of clinical studies to support the pipeline of products. This is a ground-up opportunity to contribute to and execute on a vision of excellence in clinical study management.
The companies main laboratory and clinical facility is based in Newcastle upon Tyne.

Responsibilities
• Accountable for the execution of clinical studies, or assigned portion of clinical studies while optimizing speed, quality and cost of delivery and compliance with standard processes, policies, and procedures.
• Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.

• Preparation of all necessary documentation and systems to support the clinical study design.
• Serving as the primary clinical study contact with the sites and/or contractor
• Monitoring study performance against contract and expectations and according to key performance metrics
• Design, implementation, and management of study database
• Ensuring compliance with study tools, training materials and standard processes, policies, and procedures.
• Prepares and/or reviews study-related or essential study start-up documents as they relate to the assigned clinical trials (e.g., Clinical Protocols, Informed Consent forms, Investigator Brochures, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters).
• Maintains a working knowledge of all study related SOP’s
• Serves as a Clinical Project Manager ensuring that the parties meet or exceeds the timelines and deliverables assigned to the study team
• Oversees/leads study-specific study management resources
• Manages relationships with sites/PIs. other study related vendors, including CRO’s.
• Knowledge of established project management standards used to develop and maintain integrated project plans (scope/work packages, time/schedule, cost/material and human resource, quality, communication/escalation, risk, value) and organizes/facilitates meetings and discussions as needed.
• Defines, tracks and reports schedule attributes such as durations, interdependencies, milestones, critical path and other key deliverables including efficiency and effectiveness of plans and staff.
• Proactively identifies and manages risks and issues (including a log, mitigations, and contingencies) to ensure cost effective timely delivery of the project including escalation if needed Plans and maintains high quality standards to meet compliance requirements.

Knowledge, Skills & Abilities
In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines and ISO 20916:2019
In depth diagnostic and protocol knowledge
Strong communication and interpersonal skills, including good command of English language and technical writing
Demonstrated ability to deliver results to the appropriate quality and timeline metrics
Strong software and computer skills, including MS Office applications
Ability to work effectively, independently with multi-level teams, manage multiple projects and work in a fast paced and changing environment.

Education & Experience
Degree or equivalent in life sciences or related field
Clinical Research Coordinator Certification or equivalent preferred.
Experience/Knowledge in IVD products, and Clinical Laboratory processes
Project management experience desirable using MS Project or similar system. PMP Certification is an asset
Experience successfully leading a project team
We look forward to receiving your application.

 

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Clinical Study Manager

Biotechnology Clinical Life Sciences Pharmaceuticals

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