Manager, Clinical Operations - Remote Opportunity
Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative pipeline, bringing forward transformative therapies to address unmet needs in neurology and psychiatry. Join us on our journey of growth!
This is a remote opportunity: Open to candidates anywhere in the greater United States
Manages the execution of multicenter, potentially multinational phase 1-4 studies and supports certain aspects of a group of clinical studies. Responsible for the project timelines, resources, and for developing the budget and overall forecast for clinical studies. Leads study specific project teams and external partnerships and collaborations.
- Serves as main point of contact for sites and CROs/vendors, enabling day-to-day contact to proactively resolve any issues as they arise in a timely manner. Creates specifications, recommendation, work order negotiation, payment structure and milestones for clinical contracts with CROs.
- Leads a cross functional Study Team including CRO/vendor staff and manages the operational tasks relating to the planning, execution and ongoing reporting of clinical studies.
- Performs the facilitation, development and implementation of clinical trials to meet or exceed development plan timelines, and to remain on budget.
- Assists with study planning, including; development of timelines, budgets and risk management plans. May assist with synopsis development.
- Manage studies ensuring adherence to country specific regulations and guidelines.
- Ensures study team activities are completed to timelines and according to the quality standards defined by regulations, relevant privacy laws, Lundbeck Code of Conduct, Lundbeck SOPs and ICH GCP. Ensure appropriate involvement and communication with relevant stakeholders are represented in the study team, Outsourcing Management, CROs as well as line managers.
- Prepares, participates and assists as necessary in audits/inspections by ensuring study essential documents are appropriately filed at site and in the Sponsor TMF and respond to audit/inspection reports.
- Ensures that quality data are produced to meet the agreed timelines of study; and compliance with serious adverse event (SAE) reporting procedures and timeframes is achieved.
- Effectively communicates (oral and/or written) project-related information including the planning and execution of meetings and presentations and work with Clinical Operations and other functional areas.
- Lead/participate in cross functional working groups/projects.
REQUIRED EDUCATION, EXPERIENCE AND SKILLS:
- Accredited Bachelor's Degree
- 3+ years’ experience in the pharmaceutical or biotech industry or in a CRO supporting the pharmaceutical or biotech industry.
- 2+ years of clinical study site monitoring experience or in-house study management experience.
- 1+ year of clinical study coordination or management for drug development.
- History of managing sites in Pharma-sponsored clinical pharmacology studies intended for use in NDA applications to FDA including monitoring visit scheduling, clinical site management, site training, site communication, query resolution, and generation of trip reports.
- Experience in effectively training site personnel in clinical pharmacology studies
- Strong knowledge of the drug development process. Versed in GCP, ICH and CFR regulations
- Excellent written and oral communication and presentation skills.
- Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities.
- Ability to manage multiple priorities, while maintaining attention to detail.
- The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire, or request a medical or religious accommodation
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
- Accredited Bachelor's Degree preferably in healthcare related field
- Prior experience with timeline and budget development for clinical study programs including outsourced work.
- Experience preparing and conducting a variety of presentation types including management and project team updates and investigator meetings.
- Experience conducting CNS studies.
- Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and EDC platforms).
- Willingness/Ability to travel up to 30% domestically. International travel may be required.
The range displayed is specifically for those potential hires who will work or reside in the states of Colorado and Connecticut, if selected for this role, and may vary based on various factors such as the candidate’s qualifications, skills, competencies and proficiency for the role. Salary Pay Range: $100,000 - $125,000 and eligibility for a 10% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our site.
Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep heritage of discovery and have brought breakthrough therapies to millions of people across the globe. And we're just getting started! Our success is driven by our great people and inclusive culture, which is guided by our beliefs of being Patient-Driven, Courageous, Ambitious, Passionate & Responsible. Are you ready to make an impact, one patient at a time?
Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.
Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.
Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.