Senior Manager, Clinical Affairs EMEA

Senior Manager, Clinical Affairs EMEA

QIAGEN

Manchester, United Kingdom

Overview

The Regional Manager of Clinical Affairs will act as the ambassador for the clinical function regionally. In addition to the day to day management of the Clinical Study Leads (both permanent and contract) within the Clinical Affairs team in Manchester, UK and Barcelona, Spain, they will perform a Clinical Study Lead role on an agreed number of projects, with the proportion of time adjusted to reflect both line management and project work commitments

Position Description

  • Responsible for managing regional Clinical Affairs team according to business objectives. Identify and cultivate talents, business continuity and succession planning, establish framework for team development and working culture in line with QIAGEN policy and competence guidance.
  • Provide training or related infrastructures to regional team members, set and assess individual goals.
  • Implement global Clinical Affairs procedures, ensuring regional clinical requirements and guidelines are also met. Oversee clinical compliance and team performance according to all international and regional standards/regulations.
  • May also be responsible for communicating with Business Area franchise lead, as the franchise clinical lead, in addition to other regional stakeholders, to provide clinical strategic insights, and oversee the deliveries of clinical strategies and plans meeting business requirements.
  • Forecasting of regional resource needs, request to global head, and responsible for managing resource and clinical expenditure in region.
  • Lead regional clinical team on business priorities, manage the complete project portfolio along the entire clinical process including planning, budgeting, evaluation, execution and management of study-related activities.
  • May collaborate with regional authorities or clinical related associations/consortium, monitor industrial trends and regulation developments, providing on time evaluation and make QIAGEN contributions to external organizations.
  • Supervise and/or lead the coordination activities related to the design, management and execution of clinical studies for worldwide product approval of in vitro diagnostic devices. This includes but is not limited to the preparation of clinical trial plans and protocols, site selection, site approvals (including ethics committee), site budget and contracting, site training and logistics, case report forms/worksheets, study binders, monitoring and all other trial specific activities.
  • Monitors the progress of clinical studies and oversees clinical site monitor activities and reporting. Communicates regularly with study investigators and internal parties regarding activities related to the clinical studies. This includes timely identification and communication of problems or issues that could affect the results or compliance of the study.
  • Participate as a core team member on assigned projects. Interface with multiple functions including regulatory, development marketing, medical affairs staff to ensure proper alignment and management of clinical studies from initiation to submission. Be a decision-leader on behalf of Clinical Affairs.
  • Develop and track key quantifiable metrics and deliver dashboards, report and analytics to leadership.
  • Prepares, reviews and approves Clinical Study Reports and clinical sections of regulatory submissions. Actively participates in responses during regulatory review processes.
  • Work closely with core teams to prepare study budgets and set timelines. Ensure studies are completed within budget and defined timelines.

Position Requirements

  • University degree in a health-related field required and experience/training in clinical study management including good clinical practice. Completed period of university education in the second study cycle. Examples of required degrees are Diploma, Master's, PhD, MBA, 2nd state examination or comparable qualification.
  • Minimum of 5 years working experience with in vitro diagnostic devices required, preferably with molecular diagnostic devices; other medical devices or pharmaceutical experience will be considered.
  • Strong attention to detail in verbal and written communication and excellent organizational skills required.
  • Proficiency in prioritizing work in tight and changing deadlines within budget and compliance with organizations SOPs and international regulation.
  • Ability to work with diverse individuals both internal and external to the organization.
  • Excellent knowledge of the in vitro diagnostic industry including product development processes (ISO13485), CLSI guidelines and ICH good clinical practice.
  • Ability to work independently while exercising good judgment and decision making within defined practices and policies.
  • Proficient in reading, analyzing and interpreting scientific evidence and technical information.
  • Ability to demonstrate and convey high performance high standards culture.
  • Proficient in English language both oral and written, additional German language skills are of benefit.

Personal Requirements

  • Willingness to travel internationally: 10-30%.
  • Strong interpersonal, teamwork skills.
  • Exceptional organizational and workload.
  • Management and planning skills.
  • To be able to take complex information and translate this into clear and concise information for non-experts.
  • Proficient in defining problems, establishing facts and drawing conclusions and mitigation plans.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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