Project Manager (Clinical Operations)

Project Manager (Clinical Operations)

Abercorn Sinclair is delighted to present this new opportunity with our industry partner Trogenix.

Trogenix, based in Edinburgh, is an early-stage biotech company developing novel therapies in the oncology field.  

The role

Reporting to the VP of Clinical Development the Project Manager is responsible for supporting the delivery of pre-clinical and clinical studies ensuring quality and compliance in accordance with applicable regulations and Trogenix Standard Operating Procedures (SOPs).  The Project Manager will lead and maintain oversight of cross-functional teams comprised of internal and external partners and is responsible for oversight of CROs and vendors and the delivery of assigned projects to timeline and budget.  

Role responsibilities

• Lead and hold accountability for the deliverables of the cross-functional Project Team and external Vendors and CROs to ensure delivery of pre-clinical and clinical programmes to time and budget in accordance with Trogenix SOPs.  . 
• Report to Trogenix Senior Management on project status, progress, risks, issues and mitigations.
• Support the identification, review, selection and contracting of CROs and Vendors
• Initiate contracts, review payment terms and vendor invoices and assist in tracking spend against approved budget(s).   Forecast and actively track study budget(s) against forecast.
• Act as primary Trogenix contact for CROs, vendors and Sites
• Drive clinical site selection and feasibility as required
• Author / Oversee development and delivery of key clinical study documents such as the clinical Protocol, Regulatory and Ethics Submissions, Project Plans, Investigator Brochure, Informed Consent Forms, Study Manuals, CRFs etc
• Author / Oversee development of key training documentation for CROs / Vendors and Sites.
• Prepare presentation material for meetings, newsletters and websites.
• Responsible for the set-up, coordination and participation in Investigator Meetings
• Develop clinical recruitment plan, drive recruitment and highlight any risks to senior management and provide mitigation strategies
• Organise or support study Safety Review Committees to assess study data and facilitate dose escalation decisions
• Conduct initial and ongoing risk assessment and mitigation plan development 
• Ensure issue escalation and drive issue resolution.  Work closely with Project Team to ensure any CAPAs are resolved in a timely manner and documented appropriately as per requirements of Trogenix Quality Management System (QMS).
• Support set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness.
• Subject Matter Expert in the assigned study Protocol(s)
• Comply with relevant training requirements and adhere to Trogenix SOPs and QMS.
• Support development and review of clinical SOPs and the development of the QMS as required
• Participate in and support audits of CROs / Vendors and Sites as required
• Participate in and support any regulatory inspections

Required Skills and Experience

• Experience managing Phase I/II oncology or Gene Therapy studies
• Experience managing global studies desirable
• Experience across all phases of start-up, delivery and close out
• Strong working knowledge of ICH-GCP, local laws and regulations
• Proven experience in driving timelines, cost and quality and leading cross-functional study teams
• Effective verbal and written communication skills leading to successful team collaboration
• High degree of flexibility, ability to prioritise multiple tasks and deliverables with a strong ethos of team collaboration
• Ability to travel

The Candidate:

The ideal candidate will be educated to BSc/MSc/PhD level in a relevant scientific discipline with several years of demonstrable clinical operations experience within the biotechnology/pharmaceutical/CRO industries. Individuals with both pre-clinical and phase I/II studies would be highly desirable.

This is a site-based role however, remote working may be supported for the right individual.

The Opportunity:

In return you will have the opportunity to join a dynamic and ambitious team working at the cutting-edge of oncology therapies. You will play a critical role in the future success of the business driving the pre-clinical and clinical programmes.

You can expect a competitive salary and full benefits package.

Company Values:

• We Act with Positivity

We are bold in our ambition and innovation, acknowledge risks, and embrace challenges with enthusiasm

• We Commit

We are accountable for our goals, act with urgency, and do what we say we will do

• We Are Transparent

We maintain transparency in every aspect of our business—our goals, planning, data, communication, successes, and challenges

• We Act with Camaraderie

We are inclusive, empathize, have fun together, trust each other, and always give our best

To Apply:

Please contact our retained partner, Keith Tocher at Abercorn Sinclair for a confidential discussion.

About Abercorn Sinclair

Abercorn Sinclair specialises in talent search and selection within the biotechnology sector, working exclusively with our industry partners to provide tailored talent management and project-based search solutions.