This is an external facing country/regionally aligned role, strategically focused on providing key local operational and scientific knowledge to drive country and regional level clinical development strategy, enabling local partnerships that enhance customer satisfaction, and support focused delivery and execution of the Biogen Development pipeline.
The CCSL role (in close collaboration with or as a direct report of the Principal or Sr CCSL) 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.
This role serves as a single point of contact for Investigators, affiliate office staff, CRO staff, and QSDO/global teams. This will enable the delivery of local clinical trials with a focus on quality, patient safety, and oversight of CRO activities and performance.
The CCSL role will serve as a site escalation point for investigator concerns, including those related to data integrity, patient safety or issues that are unresolved by the CRO, so that these may be communicated to the appropriate Biogen responsible party.
Maintain up-to-date local knowledge of therapeutic/ disease areas researched by Biogen, standards of care, clinical trial requirements, and trial-related needs of clinicians in the community. Provide and manage investigator and site knowledge/relationships to highlight country-level capabilities, interests, needs, and satisfaction levels. This may involve the development of a country-level QSDO investigator engagement strategy, or execution of a global strategy (in collaboration with WM or local medical), as applicable, to position Biogen as the company partner of choice for clinical trials.Support local activities as part of the 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 act as primary country-levelQSDO/Biogen contact accountable for strategic development and execution of country activities related to the required sponsor oversight of CRO and clinical trial activities, include, but not limited to; Sponsor Oversight Visits (SOV), audits and inspection support. During SOVs, the aCCSL may perform co-monitoring tasks such as: reviewing written informed consents, source documents, and other trial records for accuracy and completeness, ensuring that they are kept up-to-date and maintained following the study protocol, ICH/GCP, SOPs and applicable local and regulatory requirements.May act as 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 staff, and GCO/global teams. Monitor, analyze, and understand overall trial and country progress to support QSDO deliverables and country-level goals, as applicable. Support local or regional projects or other CSO activities as a representative of their countries (Brazil and Argentina).
QualificationsMinimum 5 years clinical research experience. Experience managing clinical trial activities desirable, especially sponsor oversight activities in an outsourced /FSP model with CROs/vendors.Understanding of cross-functional drug development process and high scientific/clinical knowledge across key therapeutic areas enabling aCCSL to discuss compound (s), development plans, and protocol endpoints with investigator site personnel.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. Ideal candidate will be customer-focused, with excellent 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, English Fluent. Spanish is a plus.Based in São Paulo - Hybrid
Additional Information
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.
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