Description

Sponsor Dedicated Clinical Trial Manager II/ Sr CTM - Home Based in SPAIN

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.  

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know: 

WORK HERE MATTERS EVERYWHERE

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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. 

Job Responsibilities

Experience as CTM in the management of global 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:

2 years or more of experience as CTM, managing global trials

Experience with vendors management is required

Oncology Experience

Language Skills: Very Fluent English

Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience

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

Good communication, presentation and interpersonal skills among project team and with sites

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.

http://www.syneoshealth.com

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.

Summary

Roles within the Clinical Trial Management job family are responsible for all aspects of the development, coordination, and implementation of Phase 1 clinical research studies at the organization's facilities. Collaborates with the principal investigator, liaisons between research subjects, client teams, investigators, and clinic operations teams, and plans logistics and resource usage. Tracks study progress in alignment with project milestones, client deliverables, and budget, and follows applicable regulations globally and by region. Impact and Contribution Includes executives as well as managers, supervisors and team leads providing strategic vision and/or tactical direction across a discipline and/or broader organization. The majority of time is spent overseeing their area of responsibility, planning, prioritizing, and/or directing the responsibilities of employees. Goal are achieved through management of process, policy, and performance of direct and/or indirect reports. Supervises experienced support employees and/or entry individual contributors. Delivers operational results that have moderate impact on the immediate achievement of results for the team. Broad job knowledge in an operational, administrative and/or specialized field, adapts new procedures, techniques, tools, etc. Understands basic management approaches such as work scheduling, prioritizing, coaching and process execution.