Evidence Delivery Associate Director - Cherry Hill, United States - TFS HealthScience

Description

Job Description

Job 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

TFS HealthScience collects and processes personal data in accordance with applicable data protection laws. If you are a European Job Applicant see theprivacy noticefor further details.

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.

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