Skip to main content

This job has expired

Principal Clinical Project Manager

Employer
Mundipharma
Location
Cambridge, Cambridgeshire (GB)
Salary
£Competitive
Start date
17 Nov 2020
Closing date
17 Dec 2020

Job Details

About Us

Since the global network was founded in 1952 by a family of physicians, the Mundipharma network has always challenged conventional wisdom, and we expect the same from our employees. If you crave the freedom to think and work in new ways, then this is the place for you. Our flat organization allows you to make decisions and deliver results fast, which makes this an exhilarating and exciting place to work regardless of your role.

Job Description

To be accountable for the delivery of clinical studies and discrete clinical study related work by managing external resource such as CROs and expert consultants as well as matrix management of internal functional representatives. Accountable for delivery of clinical studies and associated work to time, quality and budget.

Duties & Responsibilities

• Strategic: expert functional area input during due diligence activities; Input into Clinical Development plans, budget forecasting for development plans; CRO and vendor management plans and knowledgebase of suitable vendors.
• Financial: Consultant/CRO contract preparation and management; budget management and invoice approval at the study level or work order level for specific contracted out activities.
• Resource: Selection and use of appropriate qualified consultants and CROs for outsourced services. Forward planning for resource needs at the study and work order level.
• Management: Responsible for delivery of clinical studies and specific study related work using internal matrix management and external oversight of CROs and consultants.
• Decision Rights: day to day decisions for managing clinical studies and outsourced clinical study related work; review and recommend approval of contracts and change orders within a clinical study.
• Key Interactions: internal functional reps and study teams; external consultants and CROs undertaking outsourced activities.
• Provide Clinical Operations input into clinical development plans. Develop synopses and protocols for clinical studies and be accountable for delivery of clinical studies across all phases.
• Consultant / CRO selection, management and oversight of outsourced activities for all activities within Clinical Operations including:
o study management activities such as project management, study planning and feasibility, regulatory and ethics submissions, use and development of clinical systems such as IRT, EDC, EPRO, site selection, patient recruitment and monitoring, TMF etc;
o data management activities such as CRF/ ePRO/ eDiary development, data checks, DMP/ data handling, data integration, Data transfer plans, data transfer specifications etc.
o data visualisation and data interrogation requirements;
o medical writing activities including IB and CSR generation;
o publication of clinical study data on public locations and in Journals etc.
• Utilise project management tools such as CTMS to manage projects through their lifecycle including contingency planning and risk management to identify any risks or issues for resolution.
• Manage internal processes and systems used for clinical study activities including ETMF, Mail archive, archiving of study data.
• Contract development, budget management and invoice review/approval
• Significantly input into the development of process improvements within Clinical Operations, maintain up to date knowledge of external guidelines and industry standards.
• Provide Clinical Operations expertise and procedural advice and support to Independent Associated Companies in various locations around the World including Europe, Asia, and Latin America for the conduct of local clinical projects.

Who we're looking for

• In depth knowledge of GCP and current legislation.
• Experience of delivering clinical studies across different phases and therapeutic areas; experience of successfully managing different vendors. Experience within Oncology or anti-infectives or orphan drug clinical study management would be advantageous.
• Ability to work cross functionally, interpret information and critically assess performance of external consultants and CROs across all functional activities, including study management, data management and medical writing. Ability to confidently lead multi-functional delivery.
• Ability to take responsibility and make informed decisions; ability to target oversight activities and build oversight plans to cover all elements of clinical study activity.
• Experience of contract development, management and oversight including MSAs, work orders, scope documentation development and change order negotiation.
• Ability to prioritise, work flexibly and think strategically.

Do you think you could help us see what others don’t? Be inquisitive and help us move medicine forward!

Company

Since the global network was founded in 1952 by a family of physicians, the Mundipharma network has always challenged conventional wisdom, and we expect the same from our employees. If you crave the freedom to think and work in new ways, then this is the place for you. Our flat organization allows you to make decisions and deliver results fast, which makes this an exhilarating and exciting place to work regardless of your role.

Company info
Website
Location
Cambridge Science Park
Milton Road
Cambridge
CB4 0AB
GB

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert