Description
Global Clinical Trial Assistant - Managed Access Programs
Home based in Belgium, Italy, Germany, Switzerland, Spain, Netherlands or Portugal
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives. 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
The Global Clinical Trial Assistant assists with local project management activities of clinical trial(s) (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include assisting with operational aspects of assigned project(s) at the country level for end-to-end project management from start-up through to closeout activities. Further, services will range depending on the therapeutic area and project-specific requirements. Reports to Sponsor Manager or designee, and partners with the Global Trial leader (GTL) to ensure overall study delivery at the country level.
Deliverables:
- Services rendered will adhere to applicable sponsor SOPs, WIs, policies, local regulatory requirements.
- Schedules study management team meetings for each project assigned and maintains documentation from meetings in appropriate repository.
- Assists in management of project budgets and Affiliate spend, reconciliation of invoices, final budget and liaises with Accounts payable, as necessary.
- Ensures study(s) compliance by maintaining and updating trial management systems, Clinical Trial Management System (CTMS), Trial Master File (eTMF) and Trial Master Source (TMS) ensuring up-to-date, complete and accurate status.
- Maintains internal project specific study sites to ensure availability of all central project documents.
- Liaises with external service providers (ESP) and contract research organizations (CRO) as needed.
- Continuous and up-to-date understanding of the study, processes and system/documentation requirements ensuring ongoing inspection readiness by complying with relevant training requirements.
- With focus on quality, supports on an ongoing basis the GTL, TM, GPL and Quality Assurance (QA) team with audit findings report and CAPA management.
- In complete partnership with the study team through the GTL, TM interactions, ensures timely document preparation and submission and approval tracking (and hence compliance with local regulatory requirements) for IEC/HA approvals, if applicable.
- Full utilization by timely and accurate time reporting.
- If applicable, region specific deliverables will be specified.
Qualifications What we're looking for:
- Associates Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience.
- Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
- Strong organizational skills.
- Ability to manage time and work independently.
- High proficiency with full MS Office Applications.
- Strong communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
- Ability to travel if necessary preferred (approximately 5%).
- High level of competence in English language.
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 S.
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