Sr. Manager, Clinical Trial Associate Line Manager

  • Full-time
  • Region: US
  • Department: Research & Development

Job Description

About the Role: 
The Clinical Trial Delivery Unit (CTDU) Sr. Clinical Trial Associate (CTA) Line Manager (LM) is a Global Clinical Operations (GCO) role. The Sr. CTA LM is accountable for the management, resourcing, development of their staff, and leading continuous improvement of the Clinical Trial Associates within the CTDU. The CTDU Sr. CTA LM reports to the CTDU, Associate Director LM.  
The CTDU Sr. CTA LM is responsible for supporting the optimization of performance of CTA study administration, processes and systems, and incorporates fundamental lessons learned to drive a culture of continuous improvement within the CTDU and GCO.  

What You’ll Do  

  • Engage with the CTDU Leadership Team to drive effective ways of working and to enhance CTA training strategy, recommend and implement tools and solutions for the CTAs, and collaborate with subject matter experts while leading or supporting key initiatives.
  • Ensure excellent study administrative performance with strict adherence to company Standard Operating Procedures (SOPs) corporate policies, procedures, and quality standards
  • Contribute to CTA capacity/resource planning activities to ensure the efficient allocation of resources and work
  • Partner with CTDU Management and other functions to establish disease unit related best practices and clinical trial innovation strategies to optimize clinical trial delivery
  • Assure adherence to GCP guidelines, processes, and procedures related to direct reports’ activities and performance
  • Contribute to the development of clinical operations expertise as needed to support the evolving pipeline
  • Develop and embed process excellence and consistency across the CTAs; effectively partners with COPL and CTL to ensure the CTAs can meet the operational needs of the clinical programs and deliver on milestones.
  • Follow established procedures and SOPs; seeks ways to improve and streamline processes to support the GCO CRO outsourcing model; provides feedback via appropriate channels for opportunities to improve processes or set best practices (i.e. PON)
  • Participate in CTDU line management activities and decision-making forums
  • Manage a team of ~8 FTEs

Who You Are:
You are independent, yet highly collaborative; broad thinker who can handle the details; assertive while being open-minded; proactive and able to react quickly. You are comfortable interacting with individuals from various areas of expertise and across levels while being scientifically and clinically astute with very strong line management and communications skills.

Qualifications

Required Skills:

  • Bachelors degree in a scientific discipline; advanced degree preferred
  • 6+ years of clinical operations Clinical Trial/Line Management experience, preferably with both a sponsor company and a CRO company
  • Critical thinking, trustworthy, reliable, emotional intelligence, collaborative, detail-oriented, resourceful, analytical skills, self-motivation and learning mindset
  • Ability to influence without authority through formal channels and informal network 
  • Ability to work with agility, taking multi-faceted approaches to transfer knowledge and know-how, and form teams for follow-through
  • Ability to evaluate resourcing and budgets, accounting, and business case development while articulating complex technical details
  • Ability to work independently and drive complex organizational processes
  • Availability for ~5% travel (to RTP, NC or Cambridge, MA)
     

Additional Information

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive. 

The base compensation range for this role is $120,500 to $194,200. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen's LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life. long and short-term disability insurances, vacation, end-of-year shutdown, and 401k participation and matching contributions.

 

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