On behalf of AstraZeneca we are in looking for a Medical Evidence Manager for a consultant assignment. The right candidate will be a process Champion for a specific area of study delivery, be the point of contact to provide guidance to MEOR colleagues on best practice. Contribute to maintaining up-to-date guidance documents and ways of working, amending where appropriate.The Arena:The MEOR Medical Evidence Manager is responsible for the activities required in the start-up and delivery of an evidence generation portfolio, including Company Sponsored studies, Externally Sponsored studies and Early Access Programs.
The MEOR Medical Evidence Manager coordinates and supports cross-functional activities, interacting with both global and local Medical Affairs organizations and those external to the Company (e.g. CRO, Sponsor Institutions and Investigators).
The MEOR Medical Evidence Manager monitors compliant and appropriate adherence with all relevant Company policies and procedures and local/ regional regulatory and legislative guidance.The Role:Company Sponsored Observational and Interventional Research Projects:
- Assist the study team with the planning of projects by providing a range of options, risk assessment and local insight that feed into the study feasibility assessment.
Externally Sponsored Scientific Research (ESR) Projects:
- Lead operational set-up and delivery for your area of responsibility; either defined studies or a sub-set of study responsibilities.
- Ensure the development and implementation of study risk mitigation plan and actions for your area of responsibility.
- Manage activities to the agreed KPI’s: time, cost and quality.
- Manage effective collaboration with internal stakeholders such as the Operations Lead (OL), Delivery Director (DD), Epidemiologist/ Medical Affairs Leader (MAL) and other internal functions, for example, to assess the impact of project changes on KPI’s.
- Collaborate with External Service Providers (ESPs) and Clinical Research Organisations (CROs) on the implementation and delivery of studies, ensuring an effective communication plan is implemented and that roles and responsibilities between parties are understood.
- Monitor the operational aspects of ESP/ CRO collaboration within your study remit to ensure they are effectively undertaken and studies are delivered to plan, managing issues and changes to the scope of projects (e.g. time and cost) as they occur.
- Act as point of contact for AZ Marketing Company (MC) stakeholders, ensuring their commitments are delivered.
- Repot on project status (using Company systems such as IMPACT and VisionTracker) and participate in project planning and control activities to ensure project plans remain up to date.
- Manage project finance within agreed threshold limits, keeping track of project budget on a continuous basis, maintaining financial management systems (such as ACCORD and OPAL) and ensure transparency with budget holders by obtaining approval for any proposed budget changes.
- Monitor compliance and ensure reporting of issues as necessary.
Minimum Requirements – Education, Skills and Experience
- Responsible for the local management and coordination of ESR studies for a given country or region.
- Acts as a point of contact for MC operational research enquiries, signposting MC to appropriate guidance.
- Supports the review of ESR proposals to enable a timely, consistent and thorough approach to evaluation e.g. gathering required data from MC, and review committee members such as Patient Safety, Regulatory, Supply chain, Medical etc.
- Lead the development, baselining and maintenance of project milestones, revising all project planning, in conjunction with MC when necessary, in light of changing needs and requirements to ensure that deliverables continue to be efficiently and effectively met.
- Leads operational aspects of ESR projects in conjunction with the clinical teams, ensuring compliance with project management guidelines, external regulations and internal processes and policies to enable the delivery of high quality Externally Sponsored Collaborative Research (ESCR).
- Tracks all project KPI’s from a time, cost and quality perspective, providing progress reports to MEOR stakeholders.
- Identify risks and escalating issues of non-performance and non-compliance to the appropriate person.
- Maintain quality and accuracy of data within the ESR registry and management tool (VisionTracker) on a daily basis and completeness of documentation to enable teams to make effective business decisions.
- Early Access Programs (EAP)/Named Patient Supplies (NPS):
- Coordinate the NPS cross functional team interactions, including any ESPs, required for granting Early Access to Investigational Medicinal Products within a defined market, region, institution and/ or therapeutic area(s).
- Ensure all relevant documentation is in place for timely review and decision making of NPS requests.
- University degree (or equivalent) preferably in medical or biological sciences or a discipline associated with clinical research. Advanced degree is preferred.
- Experience within the pharmaceutical industry or similar organisation or academic experience.
- Demonstrable understanding of the drug development process in various phases of development and therapy areas across all stages.
- Demonstrable understanding of the relevant clinical research guidelines, e.g. GCP.
- Project Management certification is desirable, or demonstration of project management skills including scope, budget, timeline, and resource management and use of associated tools.
- Evidence of working effectively with both internal and external stakeholders across regions, functions and cultures in a matrix organization.
- Experience and/ or knowledge of operational compliance for ESR. Exhibit AZ Leadership Capabilities at level 2: Drives Accountability, Works Collaboratively and Strategic Leadership.
- Ability to demonstrate AstraZeneca values in their day to day work.
- Proactive communicator in English (written and verbal skills).
- Demonstrated ability to set and manage workload priorities, resources, performance targets and project initiatives for a given project(s).
- Ability to identify and champion more efficient and effective methods/processes whilst operating with required policies and regulations.
- Flexibility and adaptability.
- High levels of enthusiasm and energy.
- Strong work ethic and integrity standards
Dfind Science & EngineeringCity:
GothenburgDeadline for applications:
2018-23 Selection is on-going and interviews will be held continuously which means the position can be filled before deadline.
Please make sure to send in your application at your earliest convenience!For more information contact:
Birgitta Nyström firstname.lastname@example.org
or Alma Zanqrelle email@example.com
Please keep in mind, e-mail applications will not be considered. Register your profile at Dfind Science & Engineering's webpage and send in your application there.Organization/Business description:
Dfind Science & Engineering is a recruitment and consulting company within science and engineering. All our consultant managers and recruitment consultants have an education and work experience within the respective field. In combination with extensive knowledge of staff issues and solid experience of recruitment, this means that we understand our clients' need for both flexibility and the right skills.
Dfind Science & Engineering is since 2016 part of Randstad Group. With over 600 000 employees in over 40 countries Randstad is the world’s second largest company within recruiting and staffing.