Overview:
We are looking for candidate locted in Hungary Only !
As a Study Delivery Specialist you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
The revised job description is to reflect:
* Role's alignment with equivalent positions in the pharma industry (in both locations) and internally with ClinOps, in regard to scope and experience
* Role's positioning in the Study Delivery Team structure and against their key stakeholders, also in relation to the
Study Delivery Specialist and Study Delivery Associate
* Expectation for the role to have a broader influence on the business, by contributing to continuous improvement initiatives across processes and systems
Job Purpose
* Study Delivery Specialist (SDS) is responsible for end-to-end operational study delivery, with the focus on completion and maintenance of internal systems/databases/tracking tools and project plans (CSAP) and supporting
Responsibilities:
Study Delivery Specialist (SDS) is responsible for end-to-end operational study delivery, with the focus on
completion and maintenance of internal systems/databases/tracking tools and project plans (CSAP) and supporting the study team in study coordination activities and administrative activities.
Depending on experience and expertise, SDS may also contribute to development/review of study documents, vendor management, cooperation with Local Operating Companies (LOCs) and other internal functions, if required. SDS is considered a key role in ensuring inspection readiness state by taking an oversight over study eTMF completeness.
SDS executes trial management activities, as delegated by Study Delivery Lead (SDL) for in-house and outsourced studies across all phases and therapy areas, in accordance with standard operating procedures, clinical operational plans, regulatory requirements and Good Clinical Practice
Working in close partnership with SDL and SDM, SDS plays a key role in successful study delivery, providing subject matter expertise across key processes and systems through the live cycle of the study.
SDS role is implemented to have a broader impact on the business, by driving continuous improvement initiatives within their remit of expertise, sharing best practices across the business, with a focus on increasing efficiency operational delivery of studies.
* Setting up and maintaining systems and tracking tools that ensure quality, consistency and integration of study data, following up on discrepancies if needed. Granting access to new system users.
* Supporting SDL in quality and data oversight to ensure inspection/audit readiness, including oversight of eTMF
completeness (eTMF setup, periodic reviews, following up on missing documents, Safety Reports Dissemination)
* Support in managing the study team's communication: meetings (preparation, scheduling, meeting minutes), info- spaces, newsletters, action logs, communication plans, team lists ect
* Coordination of the study budget -managing expenses, tracking updates, checking consistency between systems and agreements and escalating issues
* Providing input to develop study specific processes and procedures, adhering to standardization and dissemination of best practices
Depending on experience/expertise:
* May be involved in reparation and update of study documents and study plans, including, Monitoring Plans, Vendor
Management Plans, Protocol Deviation Management Plans, Risk Management Plans, Communication Plans ect
* May act as Local Operating Companies liaison / oversight - including tracking of recruitment progress, data
completeness and compliance, local budget oversight, protocol deviations oversight, supplies' availability, regulatory
approvals and import license status
* May be involved Vendor management & CRO oversight - agreeing on study-specific setup requirements, ensuring continued monitoring of agreed delegated activities
* May contribute to Risk management - contribution to maintenance of a comprehensive risk management plan and
risk tracking
* May be involved in clinical supplies and recruitment materials management - having oversight on study level supplies availability, recognizing and communicating issues to continuity of supplies, proposing solutions as appropriate
Qualifications:
Minimum Level of Job-Related Experience Required Why is this level of experience required?
Graduate or Bachelor level with at least 1+ years of relevant working experience in pharmaceutical / scientific environment.
Scientific background and knowledge of clinical trials
(including ICH-GCP) is an asset.
Foundation experience in clinical trial delivery, including processes, regulations, operational best practices, industry
standards. Well familiar with key systems used in clinical trial delivery. Experience of using Trial Master File industry accepted standard
Strong project management skills (preferably with
analytical/financial skills).
Given the interactions with multi-disciplinary teams a proven experience in clinical operations and/or study management is required and the need to be able to support pivotal and
critical studies with good quality and at a pace that meets the job requirement
List below any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational
Good knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical
Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
Ability to manage multiple competing priorities within various clinical trials with good planning, time management and prioritization skills
Able to think independently, analyse and solve problems systematically and creatively and able to take a risk-based approach
Logical/ Analytical and an inclination to spot patterns and outliers. Quality mindset, critical sense, attention to details. Promotes a total quality culture.
Good understanding of the principles of project planning & project management
Basic knowledge of project finance and accounting principles in order to understand budget, invoices, cross-charges and expense reports. Tools knowledge like Microsoft office (Excel, PowerPoint, Word, Outlook, etc.). Knowledge of Advanced Excel, timelines/budget tracking system or clinical trial management system are an asset
Excellent stakeholder management and communication skills (oral & written) and interpersonal skills
Stress resistant. Results driven and efficient. Motivated and dynamic personality. Able to evolve in a changing and challenging environment
Acts as role model in line with GSK core values and expectations. Team spirit and ability to work across cultures and geographies with a high awareness and understanding of cultural differences. Effective training and mentoring skills
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
* Various annual leave entitlements
* A range of health insurance offerings to suit you and your family's needs
* Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
* Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
* Life assurance
* Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
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