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Biogen

Associate Clinical Country and Site Lead (West Coast/Midwest)

RemoteUnited States only
Published
Role
Operations
Experience
Senior
Company size
Mid-size
$116k–$155k/yr
Check eligibility

Open to US only. Set where you work from to check your eligibility.

No BS summary

Experienced clinical research professional with 5+ years in clinical trial activities and strong site management. Must understand ICH/GCP, country regulations, outsourced/FSP monitoring models, and be willing to travel up to 80%. US remote role targeting West Coast or Midwest.

Required languages

English

What you'll do

  • Maintain current awareness/information pertaining to local clinical knowledge of disease areas researched by Biogen, emerging standards of care, and trial related needs of clinicians in community.
  • Hold specific operational and scientific discussions and act as local Quantitative Sciences & Development Operations (QSDO) expert for the provision of country level therapeutic area, disease area, and program and study information to drive and support global operational strategy.
  • Coordinate cross functional local affiliate input as required to provide appropriate country level input into Clinical Development Plan.
  • Provide and manage investigator and site knowledge/relationships to highlight country level capabilities, interests, needs and satisfaction levels.
  • Develop a country level QSDO investigator engagement strategy, or execute global strategy in collaboration with Worldwide Medical or local medical to position Biogen as the company partner of choice for clinical trials.
  • Lead and/or support required local activities as part of agreed country and sites selection process to ensure appropriate input is sought from local treating physicians and other stakeholders.
  • Serve as primary country level QSDO/Biogen contact for all QSDO clinical studies, leading interactions to ensure timely local information flow and resolution of issues with Investigators, affiliate office staff, CRO/FSP staff, and QSDO/global teams.
  • Understand, analyze and monitor overall Country Performance (KPIs) and support country focused activities to deliver country operational milestones.
  • Support special projects or other QSDO activities as a representative of CSO or Country.
  • Support study start up, site engagement initiatives, resolve site challenges and maintain oversight throughout the trial lifecycle.

What they require

  • Bachelor’s degree or equivalent.
  • 5+ years clinical research experience including managing clinical trial activities desirable, especially sponsor oversight activities in an outsourced/FSP model.
  • Understanding of cross-functional drug development process and high scientific/clinical knowledge across key therapeutic areas.
  • Understanding of ICH/GCP, applicable country regulations and clinical trial monitoring in an outsourced model.
  • Strong organizational skills, especially project management skills, with an ability to set clear goals, align priorities and execute on multiple tasks/activities.
  • Effective working knowledge of relevant IT tools to promote virtual team working.
  • Excellent knowledge of clinical operational activities/challenges across local geography.
  • Proven ability to handle a high volume of tasks of varying complexity within a given timeframe and in consideration of relative priorities.
  • Strong communication skills, including English language skill in countries where English is not the primary language.
  • Ability to assimilate new knowledge rapidly.
  • Willingness to travel up to 80% (1x/week).
  • Preferred: Experience working in a fully outsourced and Functional Service Provider (FSP) models.

Benefits

  • Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities.
  • Medical, Dental, Vision, & Life insurances.
  • Fitness & Wellness programs including a fitness reimbursement.
  • Short- and Long-Term Disability insurance.
  • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31).
  • Up to 12 company paid holidays + 3 paid days off for Personal Significance.
  • 80 hours of sick time per calendar year.
  • Paid Maternity and Parental Leave benefit.
  • 401(k) program participation with company matched contributions.
  • Employee stock purchase plan.
  • Tuition reimbursement of up to $10,000 per calendar year.
  • Employee Resource Groups participation.
  • Opportunities for learning, growth, and expanding skills.

American multinational biotechnology company

BiotechMid-sizebiogen.com/
$116k–$155k/yr