CTM or higher - Sponsor dedicated / Homebased ? everywhere in Spain | Syneos Health Clinical

Welcome to the Latest Job Vacancies Site 2023 and at this time we would like to inform you of the Latest Job Vacancies from the Syneos Health Clinical with the position of CTM or higher - Sponsor dedicated / Homebased ? everywhere in Spain | Syneos Health Clinical which was opened this.

If this job matches your qualifications, please send your application directly through our latest Job site. Indeed, every job is not easy to apply because it must meet several qualifications and requirements that we must meet in accordance with the standard criteria of the Company who are looking for potential candidates to work. Good job information CTM or higher - Sponsor dedicated / Homebased ? everywhere in Spain | Syneos Health Clinical below matches your qualifications. Good Luck: D

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...

Description

• Location: Homebased

• Type of contract: Permanent

• Starting date: ASAP

• Job title: CTM or higher

Are you looking for apany that support professional development opportunities, and promote work-life balance?

Get to know Syneos Health

We are the only full-service biopharmaceutical solutionspany in the world. That means we bring together the best clinical andmercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of. As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

Why Syneos Health?

• #SyneosHealthLife means we’remitted to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.

• We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a .

• We are continuously building thepany 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

You will have the opportunity to:

• Support the development and review of the Clinical Study Blueprint (CSB) and Protocol, and all Amendments and/or Administrative Changes. Protocol Development

• Manage the execution of the CDAs; support SPM in the creation of overall study budget (working with the contract/budget analyst); support site contract amendments and negotiation; manage invoices Budget

• 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 Country and Site Feasibility and Selection

• stay informed of progress with CDAs, CSA and site budgets; support sites for contract amendments; assist with negotiation for site contracts Site/Country Contracts and Budgets:

• oversight of site payments (US) and vendor payments, if applicable Financial/Payment Management

• draft and facilitate the Clinical Study Budget review Study Budget Financial Reconciliation

• Support the planning for the clinical study timelines by the SPM, support the SPM in the review, finalization and update of clinical study timelines; and manage the study team to meet all timelines Clinical Study Timelines:

You will be responsible for:

• Assist with selection of vendors; Create and manage Vendor Oversight Plan for each vendor; review vendor contracts, SOWs and Change Orders; day to day oversight of vendors Vendor Oversight

• creating charter, assisting with member selection, contracting as needed, updating Annual Plan Establish Review Committees:

• develop site closure plan Site Closure Strategy

• Oversight site process, ensure CRAs follow GCP and SOPs Site PI Change Process:

• assist SPM in development of patient recruitment strategy and plan; develop recruitment materials; drive strategies for needing new sites Patient Recruitment Strategy:

• Support customization of study/country/site specific Expected Document List (EDL); upload documents, reference Master File Index; oversight of TMF health; TMF reconciliation; TMF archival; quarterly TMF review Trial Master File:

• develop initial Risk Assessment and Mitigation Plan (RAMP) and maintain throughout study; responsible for Issue Management throughout the study; quarterly Issues review Risk Management

• responsible for building the study specific ICF incorporating appropriate study specific language and safety language ICF and Study Specific Language:

• responsible for assisting with agency responses CTA submissions and approvals

• KOM 1, KOM 2, IM, Clinical Study Team meetings, vendor meetings, CSM meetings as appropriate; responsible for agendas and meeting minutes, and running several meetings, HoS meetings, Vendor meetings Meetings

• Keep CTMS (Tesla) updated at study level Clinical Trial Management System:

You will play a key role in:

• Assisting / supporting 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 Study Team Training

• Assisting SPM in planning for the Investigator Meeting; creation of and collection of ses from all functional areas to create the final master deck for the IM; presenting at the IM, filing documentation of training Site Training

• Reviewing of IDRP, EDC Specs, IRT Specs, DM Plan, ePRO Specs Data Management Strategy

• Reviewing updates to IDRP, EDC Specs, IRT Specs, DM Plan; Interim/Final Database Lock

• Preparing (drive study DBLpleteness); Interim/Final Database Lock Preparation (Responsible for study DBLpleteness) Data Management and Closeout:

• Site Selection Plan, Study-Specific Issue Management Plan (SSIMP) , Vendor Oversight Plan, TMF Artifact Map and Plan, Monitoring Plan (CSM responsible), IDRP (DM responsible), EDC Specs (DM responsible), IRT Specs (DM responsible) Plans

• Assessing and reviewing of materials by external vendors (lab kits, ePRO devices, eConsent tablets, etc); facilitate return of all study equipment and materials (per country); reconciliation of all study equipment and materials (globally) Clinical Supplies (non-drug)

• Working with CDM to initiate and manage the labeling and shipment of IP throughout the study; responsible for overall study reconciliation of IP Investigational Product

Note: Every study team operates a little differently and thus the role of the SMA may vary, but these are the primaryponents of the role. The SMA should be working towards a level of independent management of a study with minimal oversight and gance.

Qualifications

What we’re looking for

• Bachelor’s degree or RN in a related field or equivalentbination 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 Gelines and other applicable regulatory requirements
• Must demonstrate goodputer skills
• Goodmunication, presentation and interpersonal skills among project team and with sites
• Strong conflict resolution skills
• Demonstrated ability to apply problem solving techniques to resolveplex issues, and apply a risk management approach toentifying and mitigating potential threats to the successful conduct of a clinical research project.
• Demonstrates critical thinking to determine the cause and appropriate solution in theentification of issues
• Moderate travel may be required, approximately 20%

Apply today to join 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 conered 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 fullyply 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 ismitted topliance with the Americans with Disabilities Act, including the provision of reasonable amodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

• Company Name : Syneos Health Clinical
• Open Position : CTM or higher - Sponsor dedicated / Homebased ? everywhere in Spain | Syneos Health Clinical
• Location Job : Madrid, Madrid provincia
• Country Job : ES

How to Submit an Application:

After reading and knowing the criteria and minimum requirements for qualifications that have been explained from the CTM or higher - Sponsor dedicated / Homebased ? everywhere in Spain | Syneos Health Clinical job info - Syneos Health Clinical Madrid, Madrid provincia above, thus jobseekers who feel they have not met the requirements including education, age, etc. and really feel interested in the latest job vacancies CTM or higher - Sponsor dedicated / Homebased ? everywhere in Spain | Syneos Health Clinical job info - Syneos Health Clinical Madrid, Madrid provincia in 17-09-2023 above, should as soon as possible complete and compile a job application file such as a job application letter, CV or curriculum vitae, FC diploma and transcripts and other supplements as described above, in order to register and take part in the admission selection for new employees in the company referred to, sent via the Next Page link below.