Senior Clinical Project Manager (SCPM)
Reports to: Head of Project Management and GxP System Application
Why you’re here
To ensure completion of high-quality clinical trials on time and within budget and be the interface with the Sponsor to ensure good communication and relationships with different stakeholders.
What you’ll deliver
- Clinical trial projects delivered on time, with quality standards and within budget
- Efficient and effective study start-up process through closeout activities
- Continuous process improvement & inspection readiness
- Demonstrated leadership in mentoring others and driving initiatives for the benefit of project management efficiency at GLC
How we’ll measure it
- Success in meeting key performance indicators for the project including, but not limited to, milestone targets, eTMF quality and maintenance, and CSM deliverables.
- Quality of relationships with internal and external stakeholders, including Sponsor clients
What you’re responsible for
- Planning, implementing and executing contracted projects while maintaining team leadership.
- Ensuring that the clinical study team drives successful completion of project milestones and deliverables within relevant time, cost and quality constraints.
- Ensuring all aspects of a clinical trial, including patient recruitment, data collection and documentation, are conducted professionally and to a high-quality standard, in accordance with policies, procedures and ICH GCP
- Serving as the primary contact between the Sponsor and the company
- Establishing and maintaining positive relationships with Sponsor clients
- Representing GLC at bid defence meetings, internal and external project kick-off meetings
- Overseeing and managing clinical trials including all aspects of clinical monitoring, investigator/site selection, site budget negotiations and preparation of study essential documents
- Study vendor management including contract negotiations, coordination of activities and timely delivery as per study timelines
- Ensuring all clinical management systems (e.g. CTMS and eTMF) and other applicable systems, are in place, accurate and consistently maintained
- Planning, implementing and managing subject recruitment plan and retention strategies
- Preparing and conducting on-site qualification, study initiation, monitoring and close-out visits, as necessary
- Escalating issues to client and GLC management when required to ensure swift resolution
- Organising and actively participating in Investigator Meetings, client meetings, project team meetings and project-specific training
- Planning and conducting country-level feasibilities
- Coaching, mentoring and developing clinical operations staff in order to meet expectations for productivity, quality and goal achievement. co-monitoring visits with junior, or new, clinical team members, as required. Coaching, mentoring and developing clinical team members seeking development in project management capacity
- Contributing to organisational strategic objectives for clinical operations department, including continuous process improvement, driving efficiency and metrics goals
- Life Sciences degree or equivalent combination of education, training and relevant industry experience
- Extensive and successful experience in the project management of complex and/or global trials with a Pharmaceutical, CRO, biotechnology and medical device background.
- Extensive experience conducting clinical trials in accordance with GCP and/or ISO methodology
- Previous cross-functional experience within other organisations.
Technical knowledge & skills or other requirements
- Extensive knowledge of clinical operations processes in all study phases and therapeutic areas.
- Deep understanding and comprehensive practical knowledge of ICH-GCP requirements & international Regulatory Authority Regulations
- Able to work in an international environment with internal & external team partners (including virtual teams)
- Highly collaborative with good stakeholder management skills
- Strategic thinking and analytical skills
- Consistently demonstrates inclusive leadership and a growth mindset development
- Strong organisational and planning skills
- Excellent verbal and written communication skills and ability to express complex ideas.
- Positive attitude and ability to interact with all levels of internal staff, clients and vendors.
- Attention to detail and ability to work simultaneously on changing and multiple priorities
- Ability to travel, as required (domestic and international)