全球资深CTM - 工作地点在西班牙。FSP. 需要供应商经验

Global Sr CTM - Home Based in SPAIN. FSP. Vendor experience is required.Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:
Why Syneos Health
• 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. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
Experience as CTM in the management of global/multiple-countries studies and different types of vendors is required
Main tasks:

• 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; and 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 Managemet 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%

Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Originally posted on Himalayas