Project Manager- CRO Job at GenesisCare
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.
Role Summary
You will be accountable for project management of clinical trials within GenesisCare Clinical CRO organisation.
Reporting lines:
As the Clinical Project Manager (CPM) you report directly to the Head of CRO.
Reporting lines and direct reports may change from time to time in line with the requirements of the role.
Your key responsibilities:
- Project management of assigned activities related to the management of multinational and local clinical trials from phase 1-4 and clinical registries.
- Manage the planning, implementation, ongoing evaluation, prioritisation, reporting and timely delivery of all operational aspects of allocated projects
- Act as the point of contact for assigned projects for sponsor and internal study teams
- Support research Business Development in the Request for Proposal (RFP) and Bid Defence processes through supporting the development of initial project plans, costings, drafting responses to RFPs and participating in client presentations
- Ensure clinical research projects are properly resourced, managed, executed and reported within budget and in accordance with established timelines and quality standards. This may include supporting vendor selection.
- Provide accurate input into standard contracts used in clinical research including Confidentiality Agreements, Letter of Intent, Indemnity Forms, Contracts for Service and Works Orders
- Work closely and effectively with sponsor study teams. Make recommendations to and seek guidance from the sponsor or the project leader.
- Provide clear project direction particularly to those sponsors who may be inexperienced in drug/device development
- Maintain effective professional relationships with sponsor, external customers, investigators, vendors and the internal project team
- Provide clear guidance to the project team on project specific deliverables as defined in contracts and project specific documentation
- Oversee the preparation of study essential documents: prepares protocol, amendments, CRF, informed consent form, operations plans and other documentation required for conduct of a clinical trial. The CPM may also prepare required regulatory documents, such as annual reports, updating of the IB, and final study reports for assigned protocols
- Oversee and manage internal clinical trial files and documents (eTMF)
- Manage the day-to-day study operations, including management of vendors (e.g., Labs, clinical trial supply companies, courier etc) and coordination of activities
- Coordinate and plan for the availability of clinical and non-clinical supplies necessary to meet study requirements
- Coach, mentor & develop project team staff in order to meet the studies expectations for productivity, quality & goal achievement. Complete mentoring and co-monitoring visits with new and other clinical team members
- Ensure that trials are managed according to corporate guidelines and objectives and that required systems and processes are in place
- Oversee and lead investigator/site selection and contract negotiations for vendors and clinical trial projects
- Coordinate and execute international study feasibilities to optimally select project study sites
- As per the business need, full site management and monitoring of the clinical studies may be requested of the CPM. Monitoring will be completed as per the protocol, relevant SOPs, ICH GCP and in accordance with specific country regulations. The CPM may also be requested to prepare and conduct on-site qualification, study initiation and close-out visits at sites
- Ensure the accurate and timely review and approval of monitoring reports and implement any actions arising
- Escalate issues when appropriate/necessary and provide feedback for the team
- Plan and implement patient recruitment and retention strategies for assigned clinical studies.
- Prepare and manage the Study Budget for assigned studies; manage purchasing and approval transactions for the project in SAP; prepare client invoices and track remittances; work with the Head of CRO in tracking and managing project team utilisation rates.
- Set up the project requirements in the Clinical Trial Management Systems and other applicable systems and ensure they are effectively maintained by all relevant project team members
- Actively coordinate and participate in Investigator Meetings as required
- Conduct and implement other activities such as writing of SOPs and Working Instructions, active participation in Team Meetings and sharing and implementing of new innovative ideas within the team
- Prepare relevant work Instructions and Forms for the project team
Your key working relationships:
As the Clinical Project Manager, you need to develop strong relationships with the following internal parties:
- Clients and potential clients
- Other CRO functional leads
- Site Research Organisation (SRO)/site research teams
- Clinicians and KOLs
- General and Operations Managers
- Shared Services
- Strategy & Corporate Development team
- Country Business Development teams
In addition, you need to develop strong external relationships with various individuals/agencies/key stakeholders.
Experience:
- Undergraduate degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals)
- Strong experience in clinical research in CRO (strongly preferable), Pharmaceutical and/or Biotechnology industry, as a Project Manager
- Formal project management certification desirable
- Proven track record of having successfully led complex global 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)
- Demonstrable experience in client interaction preferably both small biotechnology and pharmaceutical companies
- Demonstrable experience in vendor management
- Deep understanding and comprehensive practical knowledge of ICH-GCP requirements, including across different jurisdictions
- Understanding of clinical trial budgets, client and site contracts and client billing
- 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 experience is highly desirable
Other requirements for this role:
- Self-motivated leader, high energy and empathy, influencing capabilities and interpersonally savvy across all levels of the organisation
- Skills in managing difficult people/clients
- Ability to think strategically and tactically about drug/device development including short- and long-term impact on clients’ business and purpose
- Demonstrated ability to handle and oversee multiple tasks and projects simultaneously and to prioritize in a meaningful way
- Excellent tactical, execution and organisational abilities
- Builds quality relationships with all levels of management, clients and cross-functional teams, drives a collaborative and long-term partnership environment
- Experience leading matrix and/or project-based teams
- Undertake travel, domestically and internationally to fulfil the requirements of the role
Our purpose
Our purpose is to create care experiences that get the best possible life outcomes. Joining the GenesisCare team means a commitment to seeing and doing things differently. Asking what if and why not? And being focused on getting the best possible outcomes for our patients.
We are a team of 2,500 professionals who believe care should be focused on the individual, not the condition. That care should be available when and where people need it most and it should be designed to help give people the best life outcomes possible. We specialise in treating and innovating in cancer and heart disease, the two biggest diseases that impact people’s lives. We’re proud that we are designing better care for more people around the world every day.
Globally, we have more than 300 GenesisCare centres to help us bring patients the right care. For radiation oncology, that includes centres in the UK, Spain, USA and Australia. We also offer cardiology and sleep services at more than 80 locations across Australia.
Today, we are a mix of highly trained healthcare professionals, innovative support staff and leaders who share a common purpose: to design care experiences that get the best possible life outcomes. We want you to share that sense of purpose, helping us deliver high quality care to the people who need it, in a way that is efficient and leverages our global network.
#LI-Remote #LI-SM1
GenesisCare is an Equal Opportunity Employer.
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