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Alpine Immune Sciences


Seattle, WA or Remote
๐Ÿ’ฐ $60k - $100k*

Director

 

Design

 

System

Training

Support

Edu

Strategy

Management

Lead

Content

Operational

Biotech

Alpine Immune Sciences

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๐Ÿ‘€ 448 views

โœ… 32 applied (7%)

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Alpine Immune Sciences is hiring a
Remote Associate Director Clinical Documents

\nAlpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie aheadโ€”guided by our core values, weโ€™ll meet these challenges. Join us!\n\n\n\n\nAlpine Immune Sciences (AIS) is seeking an Associate Director-Clinical Documents (eTMF) to serve as an operational lead for management and oversight of the trial master file (TMF) system at AIS.  This person works in partnership with the study teams in order to ensure trial documents are complete, high quality, and appropriately filed within the TMF system. \n \nDuties and responsibilities:\nยท         Establish strategy for development and management of paper and electronic Trial Management File (eTMF) system through project management and hands-on participation in the configuration and maintenance of the eTMF for each study.\nยท         Support authoring of TMF Management Plans and provide TMF Indices; work with study teams to check and verify these plans.\nยท         Provide guidance on best practices for clinical trial records handling, retrieval, and archival procedures.\nยท         Prepare and maintain manuals, training materials, policies and procedures and other quality documents as they apply to TMFs.\nยท         Participate in and oversee the quality control of documents (paper and electronic) submitted to the TMF.\nยท         Support the coordination of the transfer of study specific TMF from CROs into the AIS TMF, if applicable.\nยท         Educate and support study teams and designated study team content owners in understanding their TMF-related responsibilities, requirements, and expectations; act as an ad-hoc member of the study team, as necessary.\nยท         Act as a point person for study team TMF questions and manage close-out of TMF related issues.\nยท         Provide TMF metrics: timeliness, completeness, and quality of TMF documentation and content, and the risk level of outstanding items as requested.\nยท         Identify any corrective actions which must be assigned and addressed.\nยท         Provide document records to users (e.g., internal staff and/or auditors) for review including archived records.  \nยท         Oversee the provision of the required documents at the time of regulatory authority inspection or internal audits.\nยท         Respond to TMF and non-TMF internal and external information inquiries related to clinical trial records.\nยท         Identify opportunities for continuous improvement.\nยท         Manage in-line QC functions for TMF documentation including site regulatory documentation to evaluate and report whether deliverables are completed per contracted services and are in compliance with all appliable local, federal, and international regulations, guidelines, AIS policies, SOPs, and work instructions.\nยท         Manage, mentor and train individuals reporting into this position, if applicable.\nยท         Actively support inspections and audits.\nยท         Resource planning to support TMF activities.\nยท         Perform other duties as assigned.\n \nQualifications:\nยท         Bachelorโ€™s degree preferred, or equivalent knowledge/experience gained through a minimum of 8 yearsโ€™ experience in the clinical trial setting required.\nยท         Must have strong knowledge of clinical drug development processes. \nยท         Understanding of the planning, launching, maintenance, and closure of Phase I-IV clinical trials, including global clinical trials. \nยท         Experience in successfully working with TMF systems.\nยท         Demonstrated successful setup and management of TMF systems. \nยท         Thorough knowledge of CFR, ICH/GCP, and GDPR/data privacy requirements. \nยท         Self-starter comfortable working in a hybrid work environment with department and cross-functional colleagues based in different geographies.\nยท         Resourceful with keen critical thinking skills; ability to successfully research a variety of topics, including obtaining input from colleagues to drive solutions. \nยท         Ability to anticipate issues and outcomes and respond strategically, proposing โ€œoutside the boxโ€, goal-oriented solutions to challenges in alignment with project and company objectives and values.\nยท         Ability to prioritize urgent and important tasks and take necessary actions to inform/escalate to management and stakeholders as appropriate.\nยท         Proven leadership and interpersonal skills with the ability to work collaboratively as a member of a cross-functional team; excellent communication and organizational skills and the ability to work effectively in a high paced, fast changing environment.\nยท         Ability to review and analyze performance metrics through various systems.\nยท         Proficiency with MS Word, Excel, PowerPoint, SharePoint; Smartsheet experience a plus.\nยท         Experience giving presentations in both department and multidisciplinary settings. \n \nEssential Traits: \nยท         Leads by example and learns from mistakes.\nยท         Effectively pivots to meet changing demands in priorities when business needs dictate.\nยท         Completes tasks on time to meet milestones, comfortable proactively communicating to stakeholders if timelines are at risk.\nยท         Clearly communicates milestones, risks, mitigations, and essential feedback.\nยท         Values the input of colleagues. \nยท         Works efficiently without compromising quality.\nยท         Continually seeks self and team improvement.\nยท         Innovates and eliminates redundant, inefficient, and manual processes where feasible.\n\n\n#LI-remote\n\n\n\n\n\nAt Alpine we engage equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. This position has a compensation range of $165,000 - $200,000. In order to be considered for a position, candidates must be located in one of the following five states: CA, MA, NC, OR, or WA. We take care of our employees with a competitive benefits package that includes stock options, annual bonus, premium medical, dental, and vision coverage for employees and their dependents, as well as life and disability benefits, FSA, and 401(k) plans. We believe quality time outside the office is vital to our employeesโ€™ satisfaction at work, so our flexible PTO plan of 160 hours, generous holiday time (generally 12 days), and parental benefits encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).\n\n\nAlpinists share a passion for meaningful work and are committed to solving the most complex problems in immunology to create new therapies for patients. We believe in innovative thinking, collaboration, flexibility, bias for action, and healthy debate. To foster our team of outstanding scientists and business professionals, we provide a premier work environment with a state-of-the-art lab and office spaces with truly inspiring views, and an open design to facilitate teamwork.\n\n\nOur treasured culture has been shaped by our diverse team who truly enjoys working and playing together. We nurture Alpineโ€™s culture in many ways, including all-company social events and happy hours, lunch-and-learn and education opportunities, interest groups like book club and movie nights, peer-to-peer recognition programs, a robust wellness program to help support physical, mental, and emotional health, and more.\n\n\nAlpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.\n\n\nOur office and lab are located in the blossoming biotech neighborhood of Eastlake in Seattle. Alpinists enjoy the flexibility to work onsite, remotely, or a hybrid schedule, with evolving options as we prioritize keeping Alpinists safe and healthy. Onsite employees enjoy an open-office layout with comfortable huddle rooms and Zoom Room-enabled conference rooms, a spacious breakroom and kitchen with a coffee bar and snacks, and rooftop access to enjoy gorgeous views of Lake Union and Gas Works Park.\n\n\nExciting challenges lie aheadโ€”guided by our core values, weโ€™ll meet these challenges.  Join us!\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Design and Education jobs that are similar:\n\n $60,000 — $100,000/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nSeattle, WA or Remote
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