Alder Biopharmaceuticals, Inc.
Clinical Project Manager
Alder is revolutionizing the way antibody therapies are identified, selected, developed and produced. Our proprietary technologies make great strides possible in the field of antibody therapeutics, yielding innovative potential new treatments for conditions such as migraine and rheumatoid arthritis.
At Alder we seek talented contributors who thrive in a high-energy team environment and want to make a real and lasting impact in the field of antibody therapeutics. Alder teams are creative, collaborative, open, committed--and central to the success of this company and its mission. If this is the kind of company you want to work for, we want to hear from you.
Alder is seeking an experienced Clinical Project Manager (CPM) to expand our growing Clinical Operations department. This position will perform a wide variety of activities to support the startup and completion of clinical research studies and may supervise other Clinical Operations personnel. This position is required to travel approximately 15-25%. This is an in-house position located at our Bothell, Washington facility.
Specific responsibilities will include:
- Manages clinical projects from concept through clinical study report completion.
- Achieves study objectives by working with team members to set project priorities and milestones and resolve project conflicts.
- Develops and tracks study timelines, budget, and quality metrics.
- Organizes and leads the clinical project team. Leads regularly scheduled cross-functional study team meetings with internal and external resources.
- Assesses the operational feasibility of studies and recommends execution and risk mitigation plans.
- Proactively identifies and resolves issues, and participates in process improvement initiatives as required.
- Ensures appropriate clinical resources are available for the clinical project.
- Participates in meetings with investigative sites, key opinion leaders and consultants, as needed.
- Manages clinical research study conduct.
- Leads the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.
- Participates in CRO and other vendor selection, negotiation and management, including monitoring of associated budgets and contracts.
- Responds promptly and appropriately to study questions and issues raised by investigative sites, vendors, monitors, and consultants.
- Participates in the analysis, summary, and reporting of clinical data through the course of the study.
- Reviews serious adverse events and other pertinent data with the medical monitor and drug safety personnel to identify safety trends and potential risks.
- Reviews monitoring reports with significant findings to confirm appropriate conclusions and actions taken.
- Ensures GCP and regulatory compliance is maintained.
- Co-monitors as needed.
- Reviews and approves invoices from study vendors, investigators, consultants, etc.
- Maintains professional expertise through familiarity with therapeutic area and clinical research literature.
- Manages, mentors, and develops direct reports.
- Participates in the training and development of all clinical staff members.
- Performs other duties as assigned.
- Bachelorís and/or Masterís degree in a scientific discipline, RN, BSN degree or equivalent.
- 5+ years clinical research experience in an industry setting and a minimum of 2 years project-lead or management experience.
- Experience in leading cross-functional teams to meet goals and metrics.
- Experience in managing Phase I, II, & III clinical studies.
- Experience in writing clinical study protocols, informed consent forms, and other clinical documents.
- Solid understanding of FDA and other regulatory requirements that may impact global clinical studies.
- Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management.
- Conscientious, influential person with an outstanding work ethic and strong personal discipline.
- Willing and capable to manage multiple projects, negotiate budgets, timelines and responsibilities.
- Excellent organizational, leadership and problem-solving skills.
- Excellent written and verbal communication skills.
- Proficient computer skills, specifically with Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook).
- Working knowledge of MS Project for development and update of clinical study timelines.
- CRA certification (ACRP or equivalent) is strongly preferred.
- Experience in managing global studies a plus.
Please send your cover letter and resume to firstname.lastname@example.org. When applying for this position, please reference job code C16-05 and let us know how you heard about this opportunity.
Alder Biopharmaceuticals, Inc.
Reference Job Code: C16-05
Alder Biopharmaceuticals, Inc. is an Equal Opportunity Employer