About the company
Our client, Genesis Research Services, brings a range of clinical trial opportunities to our community including world-first studies for pain management. As the Medical Director, Dr Marc Russo, a globally recognised Pain Medicine Physician and leader in his field, provides pharmaceutical, biotechnology and clinical research organisations with a dedicated team and purpose-built facility designed around the needs and requirements for conducting clinical trials.
About the role
Located in Broadmeadow, Newcastle, your key responsibilities will be to provide leadership and guidance to the Genesis Research Services team to ensure that all studies, research network and supporting services are conducted in accordance with the right standards, SOPs, guidelines, and regulations. You will be responsible for the smooth running of operations of the business including HR, financial management and service delivery quality.
Reporting to the Medical Director, you will manage the following responsibilities (but not limited to):
- Planning, developing and implementing strategic goals
- Ensuring sound conduct of clinical trials, including agreements, budgets, protocol interpretation, recruitment, screening, enrolment, and follow up of eligible subjects according to protocol requirements.
- Conducting feasibility analysis for all new trial protocols
- Developing and reviewing study-specific project management plans
- Directing and overseeing workflow, collaborating with clinical trial staff to ensure timely delivery of milestones
- Managing the business toward profit goals and efficiency of resources
- Communicating with sponsors and CRO's reporting study progress and issues
- Evaluating and maintaining quality and integrity of site practices, maintains ISO9001 Certification
- Performance managing, recruiting, mentoring and the day-to-day supervision of the team
- Providing and facilitating protocol and related study training to assigned staff
- Acting as the escalation point for site/trial related issues and concerns
- Managing site performance by tracking regulatory submissions, patient recruitment, case report form (CRF) completion, and data query resolution
- Providing support for site audits/inspections, as needed, and follow-through with audit/inspection findings to resolution
- Traveling and attending investigator study meetings locally, nationally and internationally
This position will require a 'blue-sky' thinker and be a Clinician with a business and commercial mind. We are looking for a strong clinical, people-focused leader, whose style will be approachable, diplomatic and represent the organisation in a professional manner. Your communication skills will enable you to engage with a very diverse range of stakeholders including Doctors, clinical staff, corporate entities, clinical research entities, and research support staff.
To be successful in this role you will possess:
- Tertiary qualifications in Sciences and/or health related field
- Business/marketing/management degree (desirable)
- Minimum 5 years' experience in clinical trials
- Strong leadership skills and experience managing a clinical trials team and site
- Superior practical working knowledge of ICH-GCP
- Sound knowledge of relevant legislation, regulations and guidelines that govern human research
- Experience managing the lifecycle of clinical trials and trials at multi-sites (desirable)
How to apply
To be considered for this role, apply now by submitting a cover letter and CV or contact Ali Kimmorley on 0421 697 428 or Wendy Donovan on 0407 525 949 for a confidential discussion.
To request an information pack please email firstname.lastname@example.org.