Clinical Project Managers required – USA – small- CRO
Upsilon Global are excited to announce their collaborating with a small to mid-size CRO who are looking to expand their Clinical Operations team in the USA. This company is looking for empathetic and self-motivated leaders to take on CTM and SCTM roles. If you’re a CPM looking for a new challenge, then this could be perfect for you!
This company strives to provide innovative treatments and answers for cancer, cardiovascular disease, and all tumour groups. This company collaborates with health professionals to deliver cancer pathways and improve the life of patients. This company is ambitious to create new technology, research and new systems, which will all help to deliver high quality care to patients in U.S. communities.
Main responsibilities and Skills
- Project management of multinational and local clinical trials from phase 1 (including First Time-In Human) to phase 3.
- Act as the point of contact for assigned projects for clients and internal study teams Act as the functional lead for project management in supporting 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 projects are properly resourced, managed, executed, and reported within budget and per 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 clients.
- Make recommendations to and seek guidance from the client or the project leader. Provide clear project direction particularly to any clients inexperienced in drug/device development
- Maintain effective professional relationships with clients, 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 and other trial documentation.
- The CPM may also prepare required regulatory documents including annual reports, updating the Investigator Brochure, and final study reports
- Oversee and manage internal clinical trial files and documents e-Trial Master File (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 and mentor & develop project team staff in order to meet the studies expectations for productivity, quality & goal achievement.
- Line-management and performance management of US-based (Senior) Clinical Research Associates and Safety Associate in a matrix environment.
- The Safety Associate will have dotted lime support from the Clinical Safety Manager based in Australia. Manage trials according to corporate guidelines and objectives and ensure 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 study feasibilities to optimally select study sites Full site management and monitoring of the clinical studies may be requested of the CPM.
- Monitoring will adhere to the protocol, relevant Standard Operating Procedures (SOPs), ICH Good Clinical Practice (GCP) and in accordance with specific country regulations.
- The CPM may also be requested to conduct on-site qualification, study initiation and close-out visits and co-monitoring at sites
- Ensure the accurate and timely review and approval of monitoring reports and implementation of any actions Escalate issues when appropriate/necessary and provide feedback for the team Plan and implement patient recruitment and retention strategies for projects
- Prepare and manage: the Study Budget; purchasing and approval transactions in SAP; client invoices and remittances; and work with the Head of Global Clinical Operations CRO in tracking and managing project team utilisation rates.
- Set up the project requirements in the Clinical Trial Management Systems (CTMS), 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 Contribute to the Quality Management System through writing of SOPs and Working Instructions, and share and implement ideas for continuous quality and process improvement within the team
- Prepare relevant Forms for the project team Act as a Subject Matter Expert for the CRO systems such as e-Clinical Trial Management System (CTMS) and eTMF and for the Project Management Function Mentor junior CPMs and oversee and advise on their project set-up and execution as required by Head of Global Clinical Operations, CRO.
Experience
- Undergraduate degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals)
- Strong experience in clinical research in CRO (essential), 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 including US-sites, 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 (strongly preferable) Demonstrable experience in vendor management
- Deep understanding and comprehensive practical knowledge of ICH GCP requirements, including across different jurisdictions including the USA Understanding of clinical trial budgets, client and site contracts and client billing (essential)
- Experience working in Oncology therapeutic areas (highly preferable)
- Able to work in an international environment with internal & external team partners (including virtual teams) and US experience is highly desirable Line-management experience (desirable)
Background
Details confidential, information available upon request
If you are interested in this vacancy, please contact me on 44 2038759966 or email me on Penny.Melson@upsilonglobal.com