Contract Specialist, Clinical Operations
Warsaw, Poland
‎18 godz. temu

Jul 26 2022

In GSK we’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI / ML) to make better predictions about who a treatment might work for, and why.

We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

In 2021 we delivered four major product approvals : Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.

Find out more : Our approach to R&D.

Responsibilities :

Responsible for coordinating and controlling contracts and other legal documents for clinical operations, communicating updates, and documenting activities in accordance with GSK SOPs and local legislation in-country andfor and Auxiliary and Other Country / ies where applicable.

May be involved or bring support to the CROs for fully outsourced studies in-country and in Auxiliary and Other Country / ies where applicable.

Accountable for negotiation and execution of investigator and supplier contracts and amendments. Responsible for ensuring all contractual terms and conditions are based on the approved GSK Master template

Accountable for negotiation and execution of other legal documents which may include, Confidential Disclosure Agreements, ICF compensation clause changes and Data Privacy clause changes.

Develop and maintain accurate tracking information related to contracts, CDAs, compensation clauses, and external costs

Develop and maintain accurate tracking information related to site and supplier contracts, and external costs. Responsible for collaborating with legal counsel and procurement to maintain Clinical Operations Master templates and service agreements (including site templates), and updating templates as required.

Ensures due diligence, TPO / TPR management of third-party suppliers is complete prior to execution of any contractual agreement.

Acts as clinical operations expert / point of contact on any contracting / legal issues, SOP interpretation, dispute resolution and proactively identifies areas of risk to Management.

Develops training materials and actively train / coach / mentor staff on contracting procedures / processes applicable to clinical research.

Responsible for reviewing benchmarking and historical data to complete the study budget build in collaboration with the Local Delivery Lead.

Responsible for leading the budget development and negotiation process with the site or supplier, ensuring fair market value and consistency while optimizing cost and minimizing risk.

Responsible for any budget updates because of protocol amendments.

Acts as consultant / expert resource with respect to study budget development and any associated systems / tools, including identifying cost variances and opportunities for cost avoidance.

Responsible for ensuring TMF completeness for all budget and contracting activities

Why You?

What skills and expertise you will bring to the role :

Master’s degree or equivalent experience ( Law, Economics preferred )

1+ years’ experience in clinical research required, with experience in area of key responsibilities. Given the need for deep expertise, a strong operational knowledge of clinical research is required.

This role requires a good understanding of local law and ICH GCP guidelines.

Good written and verbal communication skills in English and Polish language.

Self-motivated with ability to work productively in a self-managed environment.

Ability to manage priorities working across several trials and study teams.

Ability to work independently as well as in a team.

Ability to recognizes potential obstacles or risks and works proactively to resolve them within set timelines. Escalates issues appropriately, articulating the actions required from members of the team.

At GSK we offer a wide range of additional benefits :

Career at one of the leading global healthcare companies.

Contract of employment.

Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit).

Life insurance and pension plan.

Private medical package with additional preventive healthcare services for employees and their eligible.

Sports cards (Multisport).

Possibilities of development within the role and company’s structure.

Personalized learning approach (internal trainings, mentoring, access to online training’ platforms : Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training).

Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities).

Supportive community and integration events.

Modern office with creative rooms, fresh fruits every day.

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