Sr. Manager, Clinical Site Lead (Chicago, Nashville)

Company: Millipore Corporation
Location: Billerica
Posted on: November 12, 2021

Job Description:

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:Provide documented sponsor site oversight at country level for USA's -development portfolio commitments as required by regulations. - With a data driven mindset utilize site performance and quality data to optimize prioritization of oversight actions as well as operate with an execution bias in support of successful -operational delivery for assigned - territory. Chicago, IL or Nashville, TN are ideal candidate locations based on territory needs. - -

• Builds and manages site relationships
• Oversees 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 EMD Serono 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 EMD Serono 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 timeWho you are:Minimum qualifications:
    • Bachelor's Degree in Life Science required, Master of Science preferred and have direct clinical operations experience.
    • Ability to work independently on assigned tasks or projects of increasing complexity - -
    • 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
    • Solid 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
    • Experience in clinical development/operations (minimum of 8 years)
    • Capability to perform self-training incl. on therapeutic area, and synthesize the key take-away points for studies under remit
    • Strong communication skills -verbal, written and listening, both in native language and English
    • Record of having worked in multiple therapeutic areas relevant to company portfolio
    • Normally receives no instruction on routine work and only general instruction on new assignments
    • Sound negotiation skills and adapting to a variety of parties
    • Record of vendor interactions
    • Detailed understanding of all aspects of clinical protocol design and implementation, clinical site monitoring as well as overall global drug development requiredWhat 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 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.

Keywords: Millipore Corporation, Billerica , Sr. Manager, Clinical Site Lead (Chicago, Nashville), Professions , Billerica, Massachusetts