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 core 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 organization. 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 learned, best practices, problem solving
Early engagement with CRO partners and RFP process
Responsible to provide 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 Organizations (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
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