Clinical Project Manager - Clinical Trials (Phase 1-Phase3)

---

Job description

Richmond Pharmacology's continued growth and development in early phase and late phase clinical trials in healthy volunteers and in patient populations is driving a significant increase in headcount across the business. We are currently seeking a Lead Clinical Project Manager / Study Manager to join the team, overseeing the operational delivery of our clinical trials.

The incoming Senior or Lead Clinical Project Manager will have extensive experience of managing phase 1 clinical trials and ideally, will have some experience with later phase trials too. Broadly, responsibilities will orient around coordinating the activities of cross functional teams and interfacing closely with the commercial team, Research Physicians, PI's and Advanced Research Science (medical writing) teams to ensure the highest level of output from each trial. You will be engaged in the management of the trial from set-up through all of the clinical and post clinical phases up to close out. You will be responsible for controlling all study documentation, quality control, management of the crucial set up phase, clinical oversight and study close out. You will also be confident overseeing and mentoring less experienced team members who are early in their careers in Study Management or on rotation in the Study Management team, as well as providing guidance and assistance where appropriate to team members from other departments who would benefit from your experience.

Key responsibilities will include:

* Preparing and reviewing all study documents, ahead of sign off

* providing input into study design, protocol development, regulatory submissions, sponsor communication etc

* Reviewing and undertaking risk assessment of study protocol and developing mitigations and contingencies via SOM and training to safeguard delivery

* Interfacing with other departments to ensure all deliverables are on target and being addressed in a timely fashion

* Ensuring staff are properly trained and that the project is appropriately resourced

* Oversight in wards on key study days to ensure processes are smooth and streamlined and volunteer experience is excellent

* Ensure effective close out, manage resolution of data queries to facilitate timely database lock and review study report ahead of submission to regulatory authority

* QC processes and documents

This is a demanding and fast-paced environment and is likely to suit someone who is self-assured and confident in making decisions within carefully defined parameters and governance regulations. You will need to be capable of establishing boundaries and communicating effectively with your counterparts in other departments to delegate tasks and oversee timely delivery. Communication skills will need to be of the highest order. While this role is more internally facing, it is essential that you are comfortable in a client facing role as you will be included in meetings with sponsors, from bid defence through to final delivery.

Suitable candidates will be:

* Academically qualified with at least a Master's degree in a life sciences subject

* Highly experienced in managing clinical trials

* Experienced in phase1 trials

* Highly literate and numerate, with exceptional attention to detail

* High energy, proactive and highly organised

If you are interested in this opportunity and would like to apply, please follow the link to register your interest via our Bamboo HR website. You will be asked to supply a copy of your CV and basic contact details.