Director Project Management (GC CRO)

Work set-up: 
Full Remote
Contract: 
Experience: 
Senior (5-10 years)
Work from: 

Offer summary

Qualifications:

Advanced degree in Life Sciences such as Biology, Chemistry, or Pharmaceuticals., At least 10 years of professional experience in clinical research within CRO, pharmaceutical, or biotech industries., Proven experience managing clinical trials and implementing organizational systems for CRO management., Deep understanding of ICH-GCP requirements and experience in oncology therapeutic areas..

Key responsibilities:

  • Oversee clinical trial operations and ensure regulatory compliance.
  • Lead and mentor the project management team, including hiring and resource allocation.
  • Manage client relationships, ensuring proactive communication and issue resolution.
  • Support business development and process improvement initiatives.

GenesisCare UK logo
GenesisCare UK https://www.genesiscare.com/uk
501 - 1000 Employees
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Job description

At GenesisCare we want to hear from people who are as passionate as we are about innovation and working together to drive better life outcomes for patients around the world.

Care to join the Team?

GC CRO is a full-service oncology CRO specialising in radiopharmaceutical development. We help pharma and biotech companies accelerate drug development, facilitate collaborative research efforts, bridge the translational gap, enhance diagnostic capabilities, and engage a global network of medical experts. Refer to our website for more detailed information: https://www.genesiscare.com/cro

We are now looking for an experienced and dynamic Research Leader to join our CRO division as Director, Project Management. This fully remote role holds accountability for the leadership and oversight of the CRO project management team. This key position oversees clinical trial operations for assigned studies, ensuring adherence to study protocols and all regulatory compliance.

Critical to your success in this role will be your ability to lead and mentor team members, build and maintain strong working relationships through proactive communication, identify and mitigate potential project risks and address issues quickly to consistently ensure customer satisfaction.

If you’re looking to join a team where your contributions truly make a difference, read on to learn more about this opportunity and what we can offer you.

More Specifically, you will:

  • Be jointly responsible and accountable with Senior Director of Clinical Operations and Safety for project profitability, financial efficiency, and client service deliverables while ensuring high levels of client satisfaction for assigned trials and that of direct reports
  • Line management responsibilities for Clinical Project Managers and Clinical Project Assistants
  • Hiring, management and development of the project management team and assignment of resources in line with project budget requirements
  • Ensure adherence to the study protocols and compliance of ICH GCP and local regulations by the Project Management team
  • Identify project risks, and together with relevant stakeholders to develop and implement effective mitigation strategies
  • Oversee customer relationships, ensuring proactive communication, issue resolution, and satisfaction.
  • Establishment and management of relationships with key vendors, service providers and external business partners
  • Partner with cross functional teams, Quality Assurance, Business Development teams to ensure consistent and excellent service delivery in line with CRO Business Strategy
  • Establish and maintain clinical study metrics to support the continuous improvement in performance, delivery and quality of clinical research and demonstrate the cost, time and efficiency gains as a result of these improvements.
  • Support with business process improvement projects and initiatives to enhance efficiencies and accountability.
  • Support business development activities, including but not limited to reviewing and providing input to Request for Proposals (RFPs) and participate in bid defence meetings
  • Support the assessment and development of new business opportunities
  • Support and contribute to the delivery of the overall CRO business strategy.

We're interested in hearing from people who have:

  • Advanced degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals)
  • Substantial professional experience (at least 10 years) in clinical research in CRO (preferable), Pharmaceutical and/or Biotechnology industry.
  • Proven experience in all aspects of clinical trial management, including implementation of organisational systems and processes for CRO management of clinical trials (eg clinical operations, finance, quality assurance, governance systems/SOPs/structures).
  • Proven track record of having successfully led Australia clinical trials, with experience across all functional capabilities involved in CRO-directed clinical research (project management, medical & scientific affairs, safety/pharmacovigilance, quality assurance, data management, site-related activities etc).
  • Deep understanding and comprehensive practical knowledge of ICH-GCP requirements, including across different jurisdictions.
  • Experience working in Oncology therapeutic areas highly preferable.
  • Able to work in an international environment with internal & external team partners (including virtual teams) and Asia Pacific, European and US experience is highly desirable.
  • Ability to manage multiple staff and prioritise work.
  • Ability to write, collate and present reports.
  • Willing and able to travel domestically and internationally as required.

Benefits of joining our team:

  • Work remotely.
  • Own your development, learn every day.
  • Opportunities to work directly with sponsor on assigned projects.
  • Internal and external training and development opportunities.
  • All employees and their family members have access to free confidential support that is completely external to GenesisCare including financial, nutritional and wellbeing coaching, legal advice & counselling.
  • Enhance your holistic wellbeing with our Full Circle wellbeing program.
  • Range of benefits available: Access to My Fitness Passport, Qantas membership discount, Anytime Fitness Gym membership discount, 12 weeks paid parental leave, Bupa discount.

About GenesisCare
By joining GenesisCare, you will be joining a highly progressive and passionate team of healthcare professionals and support staff, united by a common purpose: to design care experiences that deliver the best possible life outcomes. The ambition for better cancer care that began our story, has grown into a passionate team of ~2,000 employees across 50 locations nationally. Join us to design better care and enjoy a career with purpose

GenesisCare is an Equal Opportunity Employer.

Required profile

Experience

Level of experience: Senior (5-10 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Quality Assurance
  • Virtual Teams
  • Problem Solving
  • Team Management
  • Communication
  • Leadership

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