Associate Clinical Country and Site Lead
Vor 2 Tagen
**Job Description**:
We are recruiting for a field-based
**Associate Clinical Country and Site Lead (f/m/d)**
**About This Role**
The Associate Clinical Country and Site Lead (aCCSL) role is a field based country/regionally aligned role, strategically focused on providing key local operational and scientific expertise to drive country and regional level clinical development strategy, enable local partnerships that enhance customer satisfaction (internal and external), and support focused delivery and execution of the R&D pipeline.
In this role you will provide global teams with detailed local operational and scientific knowledge that will inform the overall clinical development strategy and ensure that local opportunities and needs are thoughtfully integrated into operational plans. (you will do this in close collaboration with or as a direct report of the CCSL, Sr. CCSL or Regional Head responsible for their countries).
At the country level, you will be a single point of contact for investigators, affiliate office staff, CRO staff, and global teams to deliver local clinical trial quality and oversight of CRO activities, with a country level focus on performance. You will also serve as a site escalation point for investigator concerns, including those related to data integrity or issues which are un-resolved by the CRO, so that these may be communicated to the appropriate Biogen responsible party.
**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 the community. Hold specific operational and scientific discussions and act as local Global Clinical Operations (GCO) 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
- Manage investigator and site knowledge/relationships to inform teams of country level capabilities, interests, needs and satisfaction levels. This would involve the development of a country level GCO investigator engagement strategy, or execution of global strategy (in collaboration with Worldwide or local medical) to position Biogen as the company partner of choice for clinical trials.
- Lead/support 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)
- Primary country level GCO/Biogen contact for all GCO clinical studies to ensure timely local information flow and resolution of issues as appropriate with Investigators, affiliate office staff, CRO staff, and GCO/global teams. Understand, analyze and monitor overall Country Performance (KPIs) and support country focused activities to deliver country operational milestones
- Primary country level GCO/Biogen contact accountable for strategic development and execution of country activities related to the required sponsor oversight of CRO and clinical trial activities (e.g. SSVs, SIVs, IMVs, COVs, SOV’s, audits, compliance and inspection support)
- Under the operational direction of Clinical Country and Site Management (CCSM), perform GCO defined, country, site, and CRO sponsor oversight activities, including SOVs, to ensure high quality execution of clinical trials and highlight local opportunities to drive operational excellence
- Support local or regional projects or other CCSM activities as a representative of their country(ies).
- Support CCSM in maintaining accurate contact lists, calendar information, SOV reporting, local clinical operational intelligence (including regulatory) and update tracking systems as needed.
**Who You Are**
You are a passionate clinical trial specialist with experience in managing phase I - phase IV clinical trial projects in industry, you love to build collaborative relationships and influence to drive forward strategies.
**Qualifications**:
- BA/B.Sc Degree
- Extensive experience of managing clinical trial activities, especially sponsor oversight activities in an outsourced model with CROs/vendors.
- Deep understanding of cross functional drug development processes and high scientific/clinical knowledge across key therapeutic areas enabling discussions of compounds, development plans, and protocol endpoints with investigator site personnel
- Requires strong organizational, analytical and leadership skills, especially project management skills, with an ability to set clear goals, align priorities and lead multiple tasks/activities
- 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
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