Clinical Project Manager/Clinical Operations Lead - outsourced to single sponsor
- Experience Level
- Experienced (non-manager)
Clinical Project Manager / Clinical Operations Lead (UK & Ireland studies)
Home-based – UK or Ireland
Here at Syneos Health we are currently recruiting for a Clinical Project Manager to be home based in the UK or Ireland. You will be fully outsourced to the client which is an exciting new partnership for Syneos Health.
Acting as Clinical Research Manager, this role is primarily accountable for the end to end performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- Main Point of Contact (POC) for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT).
- Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
- Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed. Performs Quality control visits as required
- Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration
- Responsible for creating and executing a local risk management plan for assigned studies
- Ensures compliance with CTMS, eTMF and other key systems in assigned studies
- Escalates as needed different challenges and issues to TA director/CRD/CQM and or CTT (as appropriate)
- Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
- Country POC for programmatically outsourced trials for assigned protocols.
- Serves local business needs as applicable in country (If delegated can sign contracts and manage budgets)
- Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies.
- As a customer-facing role, this position will build business relationships and represent the company with investigators
- Shares protocol-specific information and best practices across countries\clusters
We have a comprehensive benefits package and offer highly competitive remuneration.
If you have the required experience for this position and are eligible to work in the required location then please apply by CV.
To find out more about our company and search and apply for other open jobs please visit our website https://www.syneoshealth.com/
Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.
The ideal candidate will need the following experience / skills to be considered:
- Knowledge in Project/Site Management.
- Previous CRA/monitoring experience
- Strong organizational skills with demonstrated success required.
- Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the TA Director or CRD
- Requires strong understanding of local regulatory environment
- Strong scientific and clinical research knowledge is required
- Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
- Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions
- Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery
- Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.
- Strategic thinking