Beyond Drug Development is a privately owned specialty CRO focusing on early-stage product development, advancing innovative products for clients worldwide.
Opportunity
Are you passionate about advancing new therapies and making a real difference in patients' lives? We are seeking an experienced and enthusiastic Project Manager to join our dynamic team, specialising in early phase clinical trials.
The Clinical Project Manager plays a vital role in planning, communication and management, not only the conduct of the project but in developing strong relationships within our team and with our clientele.
With the ever-evolving industry landscape, we offer an oasis where we value our people by providing a flexible working setting and a collaborative environment where everybody's experience, opinions and ideas are not only heard but actively sought. We have a values-driven culture that is built from the ground up. Our leaders are at the frontline with you, committed to advancing science and going above and Beyond for or clients but most importantly, for our team.
As a boutique early phase CRO we offer a unique opportunity to be a part of an incredibly exciting journey as Beyond continues to grow - one you can't get anywhere else, with a team unlike any other.
This position is advertised as a remote (work from home) full-time role. Candidate must live in Australia to be eligible. Advertised as Brisbane but welcome applicants anywhere in Australia.
What you will do
* Proactively manage project level operational aspects of the team including management of trial timelines, budget, resources and third parties/ vendors.
* Tracks and forecasts budget, metrics, timelines progress and deliverables for all project deliverables including vendor management.
* address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team.
* Act as the primary contact for sponsor as well as managing clients' expectations
* Report to Director of Clinical Operations and Senior Management (as required) with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.
* Coordination of all contracted interdepartmental project team members.
* Ensures project team members have all required resources necessary to complete their assigned tasks.
* Ensure all project team members comply with company SOPs, guidelines and policies at a project level.
* Effectively provide support to Clinical Research Associates and other key project members in the conduct of the trials.
* Collaborates with the Business Development team to generate a project budget, site feasibility and project strategy development.
Competencies/Experience/Qualifications
* A degree in life sciences or equivalent health related field
* At least 2 years Clinical Project Management Experience (in ether CRO, Pharma or Biotechs)
* Excellent knowledge of ICH GCP
* Excellent Knowledge of Australian regulatory environment
* Superior interpersonal, oral, and written communication skills in English
* Strong Leadership Skills
* Exceptional time management and organizational skills with attention to detail
* Knowledge of the pharmaceutical industry, terminology, and practices
* Ability to work with minimal supervision
* Ability to problem solve
* Proficiency in Microsoft Office software (including SharePoint), eTMFs and EDC Systems
* Strong attention to detail and focus on quality of work
* Strong organizational and problem-solving skills
Beyond Drug Development BDD