Evidence Delivery Director

hace 2 meses

Barcelona, España TFS HealthScience A tiempo completo

TFS HealthScience is excited to be expanding our **SRS **team and we are looking for an experienced, highly motivated **Evidence Delivery Director** who shares our vision of providing clinical research excellence. Our **SRS** team is a highly experienced international group of professionals led by an industry expert.

We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.

Our cores values of Trust, Quality, Flexibility, Passion and Sustainability are what makes TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organisation.

**Together we make a difference.**

TFS HealthScience is looking for an **Evidence Delivery Director** in Barcelona.

**What can we offer you?**

A great place to work where you will get the chance to push your career to the next level, a global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients. Spain benefits include:

- Private Health Coverage
- Global General Liability Insurance
- Global Travel Insurance
- Homebased Allowance for home-based employees
- Lunch Allowance
- Flexible working schedule

**Responsibilities**
- Cross functional collaboration and stakeholder management to drive operationally viable outcomes
- Operational delivery input on feasibility of a proposed study or project
- Contribute to Governance reviews of global studies (also including local studies upon agreement EDGD) and other relevant forums as required (e.g. GPT, JPT, etc...)
- Support the development of one-pagers in close collaboration with Payer & Strategy Leads
- Process improvements, e.g. RFP process, ballparking, feasibility, etc
- Mentoring, sharing of lessons learnt, best practices, problem solving
- Early engagement with CRO partners and RFP process
- Responsible to provide the insights on operational feasibility during the SDC development process.
- Drive the process of coordinating protocol development by ensuring input of all relevant cross functional (internal) and external stakeholders
- Responsible to provide input on operational feasibility of the protocol
- Core member of ERT and other planning/life cycle meetings, representing Evidence Delivery to provide operational expertise into Study Design Concepts and Study Protocols
- Plan & ensure adherence to all internal, study governance processes (e.g. ERT, MARC)
- Lead the process for selection of External Service Providers (ESPs), including Clinical Research Organisations (CROs)
- Collaborate with CRO/ESP to ensure the study operational aspects are effectively undertaken and ensure that study delivery is within time, cost and quality limits - Manage study specific issues and escalations with ESPs/CROs
- Set up study team and manage study resourcing
- Effective collaboration with the scientific/medical counterpart, the Epidemiologist/Global Medical Affairs Leader (GMAL)/TA Medical Head respectively, as well as other internal cross functional global roles
- Report study updates from a time, cost and quality perspective to internal stakeholders and also Joint Product Team (JPT) meetings.
- Clarify and document an effective communication approach, as well as roles and responsibilities between the BPM Evidence stakeholders, local AZ and External Service Providers
- Ensure appropriate level of involvement of the external scientific community (e.g. (Inter)national Coordinating Investigators, Steering/Executive Committee) during study design and delivery
- Develop and maintain the overall study budget (internal and external study costs)
- Keep transparency on study budget and changes through relevant systems (such as ACCORD) and platforms (Planning Performance and Control (PPC) meetings) and obtain approval for budget changes
- Work with procurement on study agreement and manage subsequent out of scope changes for ESP/CRO
- Manage and reconcile Contracts, POs and invoices
- Financial audit readiness and Sox attestation
- Key player in process improvements across Global Evidence Delivery
- Deliver studies to agreed timelines (scorecard), within the approved budget and according to client quality standards
- Ensure global oversight over the operational study start up, implementation and closure and ensure inspection readiness
- Lead study related change management within business strategy, such as assessment of scope changes.
- Ensure Compliance with client Procedural Documents, Standards and Policies, international guidelines and

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