Clinical Country Site Lead

Biogen

98d • $131,000 - $175,000

About The Position

This is a field-based country aligned role, strategically focused on providing key local operational and scientific expertise to drive global clinical development strategy, enable local partnerships that enhance global customer satisfaction (internal and external), and support the country focused delivery and execution of the R&D pipeline. The Clinical Country and Site Lead (CCSL) role will provide global teams with detailed local operational and scientific knowledge to inform the overall clinical development strategy and will ensure that local opportunities and needs are thoughtfully integrated into operational plans. At the country level, this role serves as a single point of contact for CRO staff, and QSDO/global teams. This is to enable the delivery of local clinical trials with focus on quality, patient safety, and oversight of monitoring activities and performance. The CCSL role will also serve as a site escalation point for investigator concerns, including those related to data integrity, patient safety or issues which are unresolved by the CRO, for example, ensuring that these are communicated to the appropriate Biogen responsible parties. As assigned, the CCSL may interact with FSP resources and support monitoring operations. The CCSL role may also provide operational direction and support prioritization of associate CCSL (aCCSL) resources.

Requirements

• B.A or B.S degree preferably in a scientific discipline.
• Minimum 8 years clinical research experience.
• Experience 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.
• Strong communication skills, including English language skill in countries where English is not the primary language.

Nice To Haves

• Advanced degree preferred.
• Experience working in a fully outsourced and Functional Service Provider (FSP) models.

Responsibilities

• 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 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 WM or local medical) to position Biogen as the company partner of choice for clinical trials.
• Primary country level QSDO/Biogen contact accountable for strategic development and execution of country activities related to the required sponsor oversight of clinical trial monitoring activities.
• Act as Lead CCSL, as required, including membership in CDT and SMT(s), coordinating Program and Study Country Foundation, investigator assessment of programs and protocols, and Site Selection activities.
• Lead interactions to ensure timely local information flow and resolution of issues as appropriate 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.
• Lead and manage required local activities as part of agreed country and site selection process.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees