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Evidence Delivery Associate Director

4 months ago

Cherry Hill, United States TFS HealthScience Full time
Job DescriptionJob Description

TFS HealthScience is excited to be expanding our SRS team and we are looking for an experienced, highly motivated Evidence Delivery Associate 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 Associate Director in Barcelona.

We look forward to receiving your application soon

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

  • Company Sponsored Observational and Interventional Research:
  • Support/coordinate protocol development and finalization
  • Manage Study Governance (post SDC)
  • Support/coordinate all internal, study governance processes (e.g. MEORT, MARC, LSPC, Clinical Challenge)
  • External Service Provider Management
  • Provide input into the selection of External Service Providers (ESPs), including Clinical Research Organisations (CROs)
  • Support strategic handover meetings and kick off meetings
  • Perform CRO oversight to help ensure project delivery within time, cost and quality
  • Collaborate with CRO/ESP to ensure the study operational aspects are effectively undertaken and that they have clear remits for delivery
  • Manage study specific issues and escalations with ESPs/CROs
  • Stakeholder Management
  • Support Project team set-up and study sourcing activities
  • Support effective collaboration with the scientific/medical counterpart, the Epidemiologist/Medical Affairs Leader (MAL) respectively, as well as other internal cross functional global roles
  • Report study updates for areas of responsibility from a time, cost and quality perspective to internal stakeholders (e.g. Evidence Delivery Associate Director(EDAD)
  • Support implementation and upkeep of an effective communication approach, as well as roles and responsibilities between the BPM Evidence stakeholders, local AZ and External Service Providers
  • Coordinate efforts/input of the external scientific community (e.g. (International Coordinating Investigators, Steering/Executive Committee) during project design and delivery
  • If leading a study, develop and maintain the overall study budget (internal and external study costs)
  • Ensure transparency over areas of budget responsibility by updating through relevant systems (s.a. ACCORD) and platforms (PPC meetings) and obtaining approval for budget changes
  • Work with procurement on project agreement and manage subsequent out of scope changes for ESP/CRO 
  • Manage and reconcile Contracts, POs and invoices 
  • Support financial audit readiness and Sox attestation as needed  
  • Support delivery of projects to agreed timelines (scorecard), within the approved budget and according to client quality standards 
  • Support global oversight over the operational study start up, implementation and closure and ensure inspection-readiness 
  • Support implementation of study-related change management within business strategy, s.a. assessment of scope changes 
  • Ensure Compliance with client Procedural Documents, Standards and Policies, international guidelines and local regulations at any time, and report compliance breaches 
  • Undertake feasibility assessments with internal and external stakeholders 
  • Manage study systems reporting 
  • Supports the review of ESR proposals and protocols to enable a consistent, high quality approach to evaluation 
  • Manage across a range of global and local cross-functional stakeholders to ensure all client obligations and responsibilities for ESR (e.g. drug supply, contracting, regulatory documentation, publication review etc.) are met 
  • Manage external stakeholder, e.g. external Investigator and Sponsoring institutions 
  • Support ESR portfolio financial forecasting and budgeting for assigned ESR studies/portfolios, utilising appropriate Company systems to facilitate awareness and understanding of ESR budget commitments (e.g. forecast versus actuals) 
  • Provide oversight to local Marketing Companies (MC’s) to ensure all operational delivery aspects of ESR are achieved within agreed timelines and budgets, to expected levels of quality, and in line with the legal and compliance requirements, escalating issues around non-attainment of performance metrics as appropriate 
  • Lead and manage aspects of the delivery of complex multi-product/country/cross regional collaborative ESR studies. Co-ordinates complex ESR in conjunction with MCs, overseeing Medical Affairs specialists and/or study management specialists to ensure compliance with project management guidelines, external regulations and internal processes/policies to enable high quality research projects 
  • Acts as the first point of contact for local MC operational enquiries 
  • Tracks all ESR study time, cost and quality KPIs, taking corrective action as required. In doing so, guides the MC in the changing of ESR study milestones and finances in light of changing needs and requirements to ensure that deliverables continue to be efficiently and effectively met 
  • Ensure operational quality and compliance with policies and procedures for ESRs globally 
  • Leads aspects of the planning, implementation and delivery of EA programmes
  • Perform vendor oversight to ensure EA Program delivery to time, cost and quality
  • Collaborate with vendors to ensure the EA Program operational aspects are effectively undertaken and that they have clear remits for delivery 
  • Manage triaging of program specific issues and escalations with internal (e.g. Global Clinical Leads, Chief Medical Office, supply chain representatives) and external stakeholders 
  • Manage the review process of NPS requests to ensure timelines for decision making are adhered to, utilising appropriate Company systems, so that a decision on the request can be returned to the patient’s physician

 

Requirements

  • Bachelor’s degree required preferably in medical or biological science or equivalent by experience.
  • Extensive pharmaceutical industry/CRO experience within clinical study/research project delivery, drug development process and relevant guidelines, for example GCP/ICH, for a specific therapeutic and geographical area.
  • Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools.
  • Scientific awareness and extensive knowledge of observational study guidelines and SOPs
  • Extensive knowledge of early and late stage Pharmaceutical Development
  • Ability to effectively work with Clinical Research Organisations/External Providers.
  • Proven ability to interact widely and effectively within the company across regions, functions and cultures.
  • Experience and knowledge within compliant management of Externally Sponsored Scientific Research
  • Persuasive communicator in English with a proven ability to work collaboratively in a multi-cultural environment
  • Open to periods of travel

 

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TFS HealthScience does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits.