Clinical Country Site Lead
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AI Summary
About This Role
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.
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 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. This would involve the development of a country level QSDO investigator engagement strategy, or execution of 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 (e.g. Sponsor Oversight Visit’s, audits, and inspection support). The Role may interact with FSP resources and may also support monitoring operations, as assigned.
- Act as Lead CCSL, as required. This includes but is not limited to membership in CDT and SMT(s), coordinating Program and Study Country Foundation, investigator assessment of (and feedback on) programs and protocols, and Site Selection activities. Also responsible for training CCSLs on therapeutic area and program, program and trial level communications, and ownership of CSO activities related to a given program or trial. (30-50% if serving in the role, depending on phase of program).
- Primary country level QSDO/Biogen contact for all QSDO clinical studies, leading 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 to ensure appropriate input is sought from local treating physicians and other stakeholders, [e.g. investigator assessment of (and feedback on) programs and protocols]
- May provide operational direction for activities of assigned associate CCSL (aCCSL)
- Support special projects or other QSDO activities as a representative of CSO or Country
Who You Are
You are an experienced research professional with strong site management experience. You excel in building effective site relationships, driving site performance, and ensuring quality execution of clinical trials. The ideal CCSL is highly collaborative and able to work cross functionally to support study start up, site engagement initiatives, resolve site challenges and maintain oversight throughout the trial lifecycle.
Why Biogen?
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.
Required Skills
- 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.
- The ideal candidate will be customer focused, with leadership skills, interpersonal skills, cultural awareness, high emotional intelligence and a collaborative decision-making approach. Must build relationships throughout and across the organization whilst operating remotely.
- 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.
Preferred Skills
- Advanced degree preferred
- Experience working in a fully outsourced and Functional Service Provider (FSP) models
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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