Loading...
Share this Job
Apply now »

We are experiencing a technical issue with the Careers Website. At the moment, applications are not possible. We are working on resolving the issue as soon as possible. Thank you for your patience.

Director CSL Americas

 

A career with EMD Serono is an ongoing journey of discovery: our 57,000 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:

 

To provide support to the CSLs in the assigned country/countries to ensure that development trials are conducted in regard to proper ethics, patient safety and in compliance with Good Clinical Practices (ICH-GCP) and guidelines and local regulations.

 

Ensuring CSLs provide adequate oversight of Contract Resource Organization (CRO) work performed within their assigned country, and that SLs are maintaining excellent relationships with local trial sites, relevant local/regional stakeholders and company organizations (i.e., local medical affairs and/or commercial).

 

Continuously monitor performance of assigned staff against applicable practices and expectations, addressing or escalating any deficiencies as required in order to maintain high performance teams. Provides leadership and strategic direction towards data-driven oversight activities, whereby driving performance and quality across assigned programs, by influencing and guiding Clinical Site Lead activities strategically in response to quality and performance oversight trends and ensuring trending and / or possibly program/study specific major observations from Clinical Site Leads are relayed to and followed up by the appropriate internal and external business partners. By leading a country/region across different activities:

 

  • to define process goals and design and document business requirements
  • to ensure harmonization and standardization of the process
  • to act as interface between functional managers and process team
  • to ensure implementation of optimization measures
  • to process monitoring/controlling, analysis and continuous improvement
  • manage company/department improvement initiatives
  • leadership role with delivery accountability

 

Who you are:

 

Minimum Qualifications:

 

Bachelor’s degree with 10+ years of experience, master’s degree with 5+ years of experience, or PhD degree with 3+ years required

 

Preferred Qualifications:

 

  • PhD in medical or life sciences
  • A minimum of 12 years of experience in clinical development/operations
  • Expert 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
  • Extensive clinical knowledge and experience in clinical development/ operations with the capacity to oversee site conduct including pharmacy, labs and other support departments for clinical trials
  • Effectively explores alternatives and positions to reach agreements and solutions that gain the support and acceptance of all parties.
  • 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.
  • Develops new insights into situations and applies new solutions to problems

 

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.

 

Job Requisition ID:  215813
Location:  Billerica
Career Level:  E - Professional (10+ years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
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.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Nearest Major Market: Boston

Job Segment: Manager, Medical, Pharmacy, R&D, Management, Healthcare, Research

Apply now »