Medical Evidence Manager – AstraZeneca Gothenburg
Personality / Commitment
ALTEN Pharma is searching for a Medical Evidence Manager for an exciting consultancy assignment at AstraZeneca in Gothenburg.
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.
As 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.
Job / Skills
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.
- 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.
Externally Sponsored Scientific Research (ESR) Projects:
- 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.
Minimum Requirements – Education, Skills and Experience:
- 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 organisation.
- 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.
For over 20 years, ALTEN has developed its business by keeping to the core values that have built up the company's success. Every year, hundreds of ALTEN consultants have been given the opportunity to embark on challenging technical projects for our customers. ALTEN has a tradition of developing products in many areas, and history in Sweden is based primarily on skills in mechanics, software and electronics. Thanks to a successful concept in which we utilize the expertise of experienced consultants and develop young abilities towards a successful career, we have gained ground in many industries. Our Pharma initiative is based on the same successful concept with the same strong structure, but in a new exciting industry and a new field of expertise that includes knowledge in chemistry, biotechnology and biomedicine.
As an employee at ALTEN, we offer you a competitive salary based on your performance and work experience. You also have the opportunity to influence your assignments, different benefits and your overall working environment as well as choose your career path. We offer a wide range of internal trainings and an opportunity to plan for an international career. It is our conviction that genuine commitment is created through choice and the ability to influence your own personal development - our business model provides that opportunity. This freedom of choice enables us to offer our clients the most committed consultants, regardless of assignments. At ALTEN, we believe in growing together!
For questions about the position, please contact Rickard Westergren, Business Manager Pharma, at email@example.com.
Ansökningstiden : 20/04/2018
Kontakt : Antonia Reimers
Region : Sweden - Västra Götaland - Gothenburg | Sweden - Västra Götaland - Gothenburg
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