Senior Manager, Clinical Site Lead - Mountain Region (Field Base)

Posted 23 Oct 2019

Colorado - all, Colorado - United States

Req Id 199337

Details

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 more than 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:

  • Builds and manages site relationships
  • Supports site-level study start-up, conduct, and close-out activities outsourced to a CRO for global
  • programs across different Therapeutic Areas, including without being limited to:
  • Supports Site Agreement negotiations, including stand-alone and Master Site Agreements
  • Identifies trends, issues and risks across sites, and works with external vendors as well as the with
  • the Clinical Trial Team to resolve/mitigate those
  • Ensures, in collaboration with external vendors as well as internal Clinical Trial Team that the sites
  • under his/her area of responsibility are activated in a timely manner and according to company’s
  • agreed timelines
  • Ensures, in collaboration with external vendors as well as internal Clinical Trial Team that the sites
  • under his/her area of responsibility deliver on expected recruitment targets, including identifying
  • reasons for non-recruitment, and identification of non-performing sites that require actions
  • Acts as liaison between the company and investigational sites building investigator and site staff
  • awareness on company compounds
  • Develops and implements a plan in collaboration with the global and local organization to raise the
  • profile of the company and its global clinical development projects with current and potential
  • investigators
  • Independently perform activities associated with the evaluation of investigational sites to build
  • company network
  • Ensures ICH/GCP/local regulatory requirements are observed
  • Proactively works with Medical/Patient/Industry Associations to build company network and to
  • promote company clinical trials
  • Develops the knowledge of site capabilities and past performance to assess their potential as
  • participating sites in company clinical trials
  • Ensures regular communication with local organizations to align interactions with KTLs and other
  • relevant local/regional stakeholders
  • Function requires domestic and international travel up to 70% of time

 

Who you are:

 

Minimum qualifications:

  • Bachelor’s degree with 8 plus years of experience, master’s degree with 3 plus years of experience, or PhD in a medical, pharmaceutical, or related field required

 

Preferred qualifications:

  • Knowledge of clinical operations (principles and concepts as well as regulatory environment)
  • Aptitude to interpret and to integrate site performance data in prioritization of oversight activities
  • Clinical knowledge and experience in clinical development/ operations with the capacity to support site conduct including pharmacy, labs and other support departments for clinical trials
  • Minimum of 8 years of experience in clinical development/operations
  • Record of having worked in multiple therapeutic areas relevant to company portfolio
  • Record of successful vendor interactions
  • Ability to build constructive working relationships with KOLs and clinical site personnel, other departments, and stakeholders to meet mutual goals and objectives.

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil 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 https://jobs.vibrantm.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 their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.



 

Apply Now

Let’s stay connected

Do you want to receive company news and information about career opportunities tailored to your preferences? Sign up here. You want to check the status of your application or change your candidate profile? Enter our job portal.

Redirect

You have accessed https://www.emdgroup.com, but for users from your part of the world, we originally designed the following web presence https://www.merckgroup.com.

Let's go

Share Disclaimer

By sharing this content, you are consenting to share your data to this social media provider. More information are available in our Privacy Statement