Marken is a wholly owned subsidiary of the UPS Healthcare division. With Polar Speed and Marken included, the UPS division staffs 128 locations with 5000 employees worldwide. Marken maintains the leading position for Direct to Patient and Home Health care services, biological sample shipments and offers a state-of-the-art GMP-compliant depot network and logistic hubs in 54 locations worldwide for clinical trial product storage and distribution. Marken’s dedicated 1200 staff members manage 90,000 drug product and biological sample shipments every month at all temperature ranges in more than 220 countries. Additional services such as biological kit production, ancillary material sourcing, storage and distribution, shipment lane verification and qualifications, as well as GDP, regulatory and compliance consultancy add to Marken’s unique position in the pharma and logistics industry.
The Senior Clinical Country Coordinator will provide direct oversight of Home Health Care (HHC) team projects on assigned HHC Clinical Trials for the entire lifecycle, start-up through close-out. The Senior Clinical Country Coordinator will work closely with the Manager of Study Start Up and HHC Nursing Networks, and Project Manager to assist in the planning, execution, monitoring and control of HHC studies.
- This role will work directly with the Manager of Study Start-Up and wider project team to ensure the successful implementation and operationalisation of global HHC studies. In addition, the SSC will guide the activities of the HHC team working on the assigned studies.
- This highly people oriented role entails leading a team dealing directly with HHC organizations, Home Health Care Agencies (HCA) and Home Health Care Providers (HHCP) as well as internal stakeholders involved in the conduct of a trial within Patient Centric Services; including Direct to Patient logistics, Kit Production, and Depot team members.
- Will oversee the successful delivery of all HHC aspects via effectively managing the team’s tasks and deliverables once a project is launched. The Senior Country Coordinator will be the primary contact for the PM throughout the project to completion.
- Project related duties for assigned projects include:
- a. Supporting Manager of Start-Up and Nurse Network with all required project related activities.
- b. Support PM team in defining scope of HHC services for assigned and potential studies
- c. Supporting the PM with the design and gaining the approval of study specific documents including the Project Management Plan, Source Document Templates, Investigator Booking Forms and Readiness Checklists
- d. Overseeing and guiding Clinical Country Coordinator and Coordinator Associates activities including.
- i. Liaising external HCAs and Marken QA team to vendor qualify HCAs and identify a suitable HHCP based on protocol requirements
- ii. Supporting the Creation and maintenance of protocol specific training templates, coordinating the translation of documents and perform training and qualification for HHCPs
- iii. Assisting with document collection at the site level – including the PI approvals of HHCPs (Delegation of Authority log)
- iv. all visit follow-up activities from start to end of each visit
- v. ensuring that Source document is complete, correct, and shared with the PI/Clinical site within project guidelines
- vi. Tracking major milestones for the study and provide updates and escalations to the PM
- vii. Reviewing patient specific source documentation for Good Documentation Practices
- Ensure project metrics / KPIs are within required target and support OpEx to identify trends, process improvements (departmental or project specific). Ensure that the budget is monitored to ensure HHC costs eg nursing cost and visits numbers are within the agreed scope. Flag any deviations or requirements for change orders to the PM
- Additional departmental related activities include:
- a. Support the Patient Centric Services Core Support Team with process improvements and documenting and updating changes
- Provide occasional need for flexible hours as required to accommodate global clients
- Perform any other reasonable duties at the request of the Line Manager
- Ensure compliance with national and international standards and legislation
- Travel approximately 15% of the time
- 3+ years of clinical research or equivalent health care experience
- 2+ years of experience in a clinical trials environment
- Bachelor’s degree in scientific discipline or equivalent experience
- Strong project management and organizational skills
- Advanced knowledge of local and global Clinical Trials Regulations
- Extended knowledge about home health care services, global project management, Applicable CFR, GCP and ICH guidelines
- Registered Nurse (RN) or LPN/LVN, phlebotomist, advanced nursing degree, i.e., Nurse Practitioner, or other equivalent medical professional experience
- Experience using word processing, presentation software, and remote connectivity technology
- Must possess critical thinking skills, be strategic, adaptable and well organized
- Operational experience in Home health care within the clinical research industry highly desired
- Pharmaceutical or CRO experience within related functions (i.e., clinical operations, project management, patient recruitment, medical and safety teams)
- Advanced professional degree (i.e., nursing, pharmacy, etc)
- Must work well under pressure and be willing to go the extra mile to meet critical deadlines
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