Job Details

ID #4023228
Estado Carolina del Norte
Ciudad Wilmington
Full-time
Salario USD TBD TBD
Fuente Kelly Services
Showed 2020-05-28
Fecha 2020-05-29
Fecha tope 2020-07-28
Categoría Etcétera
Crear un currículum vítae

Evidence Delivery Manager (EDM)

Carolina del Norte, Wilmington 00000 Wilmington USA

Vacancy caducado!

Kelly Services is currently seeking a Evidence Delivery Manager (EDM) in Wilmington, DE to work a contract assignment of 12 months for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100™ companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.Primary Responsibilities of the Evidence Delivery Manager (EDM) includes:

Evidence Delivery Manager (EDM) will lead or support the operational planning, delivery, oversight and budget management of company and/or externally sponsored research. They may also help coordinate the efforts of extended team members, notably the scientific study leader (epidemiologist for observational studies, Medical Affairs Leader for interventional studies). The EDM may own specific areas or deliverables within a study, or in some cases, assume the accountabilities of a team leader for study delivery.

In addition, the EDM will support continuous improvement by developing expertise in a specific area of study delivery, serving as a point of contact for best practice, and contributing to the development and maintenance of guidance documents and training materials.

The EDM’s focus will be on one of the 3 main types of work as described below- Specific activities/responsibilities per type of study:1) 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 internal stakeholders, local and External Service Providers

Coordinate efforts/input of the external scientific community (e.g. (Inter)national Coordinating Investigators, Steering/Executive Committee) during project design and delivery

Manage study finance:

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

Other Project Management activities as applicable

Support delivery of projects to agreed timelines (scorecard), within the approved budget and according to the company’s 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 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

2) Externally Sponsored Scientific Research (ESR):Delivery:

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 company 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

3) Early Access (EA) /Named Patient Supplies (NPS):

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

Typical Accountabilities-Independent of the study type, key accountabilities of the Evidence Delivery Manager are:

Management of study Governance processes

Management of internal and external stakeholders

Finance Management support

Project Management of owned study areas to deliver according to cost, time and quality

Support of study Risk Management and Quality Management activities

Study compliance

Note - additional accountabilities around finance management and team resource management may be relevant when assuming a study leadership role.

Additional Information:

Contract assignment, duration 12 months.

Work schedule: full-time, first shift.

Kelly Temporary Employee Perks:

Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchase—and the coverage is portable

Service bonus plan and Holiday pay plan, if qualified

Weekly electronic pay options

Free online training campus available

Exclusive online employee community

Corporate discounts

Apply Now!This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position you must submit your resume to the Scientific Recruiter listed below:Please email your resume directly to Sandy at: [email protected] [reference BH Job #1737728]Thank you for your interest in the assignment.Why Kelly ® ?Kelly® Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly ®At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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