$150K — $200K *
Alpine Immune Sciences is applying our platform discovery technology to bring innovative new therapies to people living with serious or life-threatening illnesses or conditions, such as cancer and autoimmune/inflammatory diseases. Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!
The individual in this role will lead and direct clinical data management efforts and initiatives for clinical trials within the AIS portfolio. This position provides functional expertise, leadership and guidance to Alpine immune Sciences and third-party team members, while working collaboratively in a fast-paced, cross-functional team environment.
Duties and responsibilities:
•Oversee and direct clinical data management (CDM) activities across multiple studies and compounds
•Represent Alpine CDM on cross-functional project teams
•Help select and manage the performance of CROs and other outside vendors
•Participate in the development/review of all CDM documentation including but not limited to eCRFs, CRF Completion Guidelines, Data Management Plans, Edit Checks, Data Review Plans, Data Transfer Specifications, etc.
•Direct data cleaning activities such as study team data reviews, SAE reconciliation, non-CRF data reconciliation, non-system edit checks
•Provide direction and guidance to team members, including consultants and vendors to achieve/meet corporate goals and milestones
•Oversees the tracking of important study metrics on data entry, source data verification, query status, data trends and presents these metrics to a cross-functional team as required
•Proactively identifies risks and executes risk mitigation strategies; Maintains timely communication with management and cross-functional teams
•BA/BS in life sciences or relevant field, with at least 10 years of relevant industry experience
•Thorough knowledge/understanding of the principles of clinical research, ICH, GCP, GCDMP, and CDISC standards
•Demonstrated project management experience with ability to perform under tight timelines while balancing conflicting priorities
•Experience working with and managing external service providers/vendors
•Cross collaboration proficiency with other functional areas with ability to work effectively in a team setting, as well as independently
•Strong organizational, time management, and resource-allocation skills with the ability to perform and prioritize multiple tasks and projects seamlessly with excellent attention to detail
•Flexible with excellent problem-solving and negotiation skills
•Relevant therapeutic experience in oncology and inflammatory disease desired
Alpinists 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.
Our treasured culture has been shaped by our diverse team who truly enjoys working and playing together. We nurture Alpine’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.
We take care of our employees with competitive benefits package which includes premium medical, dental, and vision coverage for employees and their dependents, wellness programs, FSA and 401(k) plans. We believe that quality time outside the office is vital to our employees’ satisfaction at work. That’s why our flexible PTO plan encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).
Alpine 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.
Our 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 during the COVID pandemic. Onsite employees enjoy 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.
Valid through: 9/22/2021
$80K — $100K *
7 days ago
$150K — $200K *
7 days ago