Senior Clinical Project Manager (SCPM)

Home »  Jobs »  Senior Clinical Project Manager (SCPM)
Full Time
Posted 3 weeks ago

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

Qualifications

  • Life Sciences degree or equivalent combination of education, training and relevant industry experience

Work 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)

Apply Online

A valid email address is required.
A valid phone number is required.