Head, Regional Clinical Operations - Americas

Posted 07 Nov 2018

Rockland, Massachusetts - United States

Req Id 183959


A career with EMD Serono is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.

Your Role:

The Head of Regional Clinical Operations for the Americas you lead Site Relationship & Operational Lead and the Clinical Research Manager teams within the region.

  • As head of Site Relationship & Operational Leads in the Americas, you are accountable for:
  • Providing direction to the Site Relationship & Operational Leads (SROLs) in the region to ensure that global trials are conducted with concern for ethics and patient safety and in compliance with Good Clinical Practice, internal policies and guidelines and local regulations.
  • Ensuring that SROLs oversee CRO work as well as develop and maintain excellent relationships with trial sites and the company’s commercial organizations in the region
  • Continuously monitoring performance of assigned staff against applicable practices and expectations, addressing any deficiency and providing coaching and mentoring as required to maintain high-performance teams
  • Ensuring development of communication skills of all SROLs under responsibility
  • As head of Clinical Research Managers (CRMs) in the Americas,
    • be accountable for clinical trial management of global Phase IV, local and/or regional clinical trials of marketed products, and registrational studies for local products for all countries within own region and therapeutic areas which includes:
    • Ensuring that local/regional clinical trials are executed and managed based on agreed budget, timelines and quality standards
    • Ensuring compliance with local/regional guidelines, GCP as well as alignment of systems and processes to Company and global standards (performance, quality, timelines)
    • Ensuring that the assigned staff members adequately fulfill their tasks and responsibilities within clinical trials according to agreed timelines, quality and budget and according to ICH-GCP, regulatory requirements and Company standards
    • Supporting assigned staff in reaching clinical trial objectives
    • Providing an interface with regional/local Medical Affairs organizations and ensuring alignment on trial strategy
  • Manage the implementation and integration of organizational changes or new roles and responsibilities and adjust and incorporate changes to existing roles as appropriate.
  • Lead and steer site management as well as central coordination for developing long-term relationships with clinical investigators, enhancing the image and reputation of the company and for providing an interface between the company, the investigator and the service provider across multiple countries
  • Anticipate and mitigate issues or risks in the region or countries with sites/investigators as well as CROs
  • Lead and coordinate study management for local clinical trials across countries in own region, phases and therapy areas
  • Ensure alignment and support of CRMs vs. local / regional commercial organization priorities for clinical trials
  • Ensure and drive CRMs support for local medical strategy across the portfolio within own countries
  • Oversee CRMs work/interaction with CROs in county to ensure local / regional trials are delivered within desired quality, timelines, and costs

Who You Are:

  • Advanced degree in life sciences or business
  • More than 10 years of industry experience with a biotech, pharmaceutical or CRO, including experience in clinical trial management and working in or managing clinical monitoring
  • At least 5 years of people and resource management, ideally in a multifunctional or multinational setting 
  • Demonstrated excellent organizational ability: time management, prioritization, able to handle and oversee multiple tasks simultaneously 
  • Demonstrated solid interpersonal skills 
  • Demonstrated good people management and coaching skills.
  • Deep understanding of regional aspects/variability of regulatory aspects and conduct of clinical trials in countries / across geographies
  • Ability to manage SROLs and CRMs across multiple countries across the entire portfolio
  • Long-term experience in managing CROs
  • Understanding of critical Health Care stakeholders across geographies
  • Ability for domestic and international travel up to 50% of the time

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at come2emd.com

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

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