Ctm or Higher - Madrid, España - Syneos Health Clinical

Syneos Health Clinical

Empresa verificada

Madrid, España

hace 1 semana

Publicado por:

Isabel García

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Descripción

Description
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Location: Homebased

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Type of contract: Permanent

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Starting date**:ASAP

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Job title: CTM or higher

Are you looking for a company that support professional development opportunities, and promote work-life balance?
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Get to know Syneos Health

We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial 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're committed 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
comprehensive benefits program encompassing your total health physical, mental and financial.
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

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:

Qualifications

You

will play a key role in: