[Hiring] Senior Clinical Trial Manager @Syneos Health

Role Description

Sponsor Dedicated Global Sr CTM - Home Based in SPAIN. Vendor experience.

• Experience as CTM in the management of global/multiple-countries studies and different types of vendors is required.
• Main tasks include:
• Protocol Development: Support the development and review of the Clinical Study Blueprint (CSB) and Protocol, and all Amendments and/or Administrative Changes.
• Budget: Manage the execution of the CDAs; support Project Managers in the creation of overall study budget (working with the contract/budget analyst); support site contract amendments and negotiation; manage invoices.
• Country and Site Feasibility and Selection: Assist in development of Investigator Site Selection Plan; attend country and site selection Jams; assist with creation of Feasibility Questionnaire; assist with Site Selection and Green Light Letters, if applicable.
• Site/Country Contracts and Budgets: Stay informed of progress with CDAs, CSA and site budgets; support sites for contract amendments; assist with negotiation for site contracts.
• Financial/Payment Management: Oversight of site payments and vendor payments, if applicable.
• Study Budget Financial Reconciliation: Draft and facilitate the Clinical Study Budget review.
• Clinical Study Timelines: Support the planning for the clinical study timelines, finalization and update of clinical study timelines; manage the study team to meet all timelines.
• Study Team Training: Assist/support in the creation/finalization of Study Specific Training (TA training, Compound, Study Design, Vendors, Eligibility, etc); facilitate training sessions; assign training as appropriate; assist with creation/finalization of Study Monitor Training materials.
• Site Training: Assist Project manager in planning for the Investigator Meeting; creation of and collection of slides from all functional areas to create the final master deck for the IM; presenting at the IM, filing documentation of training.
• Data Management and Closeout: Review updates to Data Management Plan; Interim/Final Db Lock Preparation (drive study DBL completeness); Interim/Final Database Lock Preparation (Responsible for study DBL completeness).
• Plans: Site Selection Plan, Study-Specific Issue Management Plan, Vendor Oversight Plan, TMF Artifact Map and Plan.
• Clinical Supplies: Assess and review of materials by external vendors (lab kits, ePRO devices, eConsent tablets, etc).
• Investigational Product: Responsible for overall study reconciliation of IP.
• Vendor Oversight: Assist with selection of vendors; create and manage Vendor Oversight Plan for each vendor; review vendor contracts, work orders and Change Orders; day to day oversight of vendors.
• Establish Review Committees: Creating charter, assisting with member selection, contracting as needed, updating Annual Plan.
• Site Closure Strategy: Develop site closure plan.
• Patient Recruitment Strategy: Assist Project Managers in development of patient recruitment strategy and plan; develop recruitment materials; drive strategies for needing new sites.
• Trial Master File: Support customization of study/country/site specific docs; upload documents, reference Master File Index; oversight of TMF health; TMF reconciliation; TMF archival; quarterly TMF review.
• Risk Management: Initial Risk Assessment and Mitigation Plan (RAMP) and maintain throughout study; responsible for Issue Management throughout the study; quarterly Issues review.
• ICF and Study Specific Language: Responsible for building the study specific ICF incorporating appropriate study specific language and safety language.
• CTA submissions and approvals: Responsible for assisting with agency responses.
• Meetings: Clinical Study Team meetings, conducting vendor meetings; responsible for agendas and meeting minutes.
• Clinical Trial Management System: Keep CTMS updated at study level.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
• 5 years or more of experience as CTM, managing multiple countries, for regional or global trials.
• Proven vendor management experience.
• Global study management experience.
• Experience in Oncology clinical trials.
• Strong experience reviewing and overseeing study plans and study-related documentation.
• Demonstrated ability to lead and align teams in the achievement of project milestones.
• Demonstrated capability of working in an international environment.
• Demonstrated expertise in site management and monitoring (clinical or central).
• Preferred experience with risk-based monitoring.
• Demonstrates understanding of clinical trial management financial principles and budget management.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Must demonstrate good computer skills.
• Strong conflict resolution skills.
• Demonstrated ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.
• Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues.
• Moderate travel may be required, approximately 20%.

Benefits

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.
• We are continuously building the company we all want to work for and our customers want to work with.