Manager, Clinical Operations - Remote Opportunity
- Working From Home
- Start date
- Nov 15, 2021
- Clinical, Clinical Research, Manufacturing & Production
- Required Education
- Bachelors Degree
- Position Type
- Full time
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.
At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen with a U.S. home office in Deerfield, Ill., Lundbeck is the only global biopharmaceutical company focused solely on brain diseases. Our legacy in neuroscience goes back seven decades and we have a long heritage of innovation. Lundbeck has developed and commercialized some of the world’s most widely prescribed therapies for psychiatric and neurological disorders. Today, we remain uncompromisingly committed to improving the quality of life for people impacted by brain disorders. Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep and productive pipeline, and we continue to bring forward symptomatic therapies to help people live better lives, while simultaneously pursuing disease-modifying treatments.
- Deerfield, IL - Lundbeck US Home Office
- LaJolla, CA - Lundbeck La Jolla Research Center, Inc.
- Bothell, WA - Lundbeck Seattle BioPharmaceuticals, Inc
Diversity matters, and inclusion creates powerful organizations To ensure that we reflect the diversity of our patients and their needs, we are focused on creating the context, culture, and systems where all Lundbeck employees - no matter who and where they are - can be their authentic self and perform at their best. In practice, this means that individuals feel empowered not despite their differences but because of them. We know that people are sometimes put into boxes - some of these boxes are of our own choosing and some of these boxes are chosen for us. For this reason, Lundbeck is taking a systematic, business-led approach to D&I that looks into and breaks down these boxes. Our bold action on inclusion includes an ambitious two-year plan that enables equality of opportunity through fairness and transparency, promotes openness, tackles bias and discrimination, and fosters belonging through our unique Lundbeck culture. From the highest levels of Lundbeck to the shop floor, we are working to ensure D&I is an integrated practice and mindset. "We win together. Lundbeck is a place where you grow and thrive – personally and professionally. We embrace the uniqueness of individuals, knowing we are stronger when every brain is in the game." Deborah Dunsire, CEO
Lundbeck offers a competitive benefits package that includes:
• Medical, dental, vision effective day 1 of employment
• Generous vacation, sick leave, holiday shut down and company paid holidays
• 401k match with immediate vesting
• Parental Leave
• Hybrid work model for office-based roles
To view more details about our Benefits, please click on the link below.
Lundbeck 2023 Benefits Summary
Sustainable Development Goals
In 2020, we based the key aspects of our sustainability strategy on the UN Sustainable Development Goals (SDGs). We found we have a significant impact on seven of the 17 Goals:
• Goal 3: Good Health and Well-being
• Goal 5: Gender Equality
• Goal 8: Decent Work and Economic Growth
• Goal 10: Reduced Inequalities
• Goal 12: Responsible Consumption and Production
• Goal 13: Climate Action
• Goal 16: Peace, Justice, and Strong Institutions
Key examples are Goal 3 that is closely linked to our corporate purpose and dedication to restore brain health and Goal 13 that drives our efforts to prepare for a zero emissions future. We will use our influence and act to promote Goals 5, 8, 12 and 16. Across our sustainability actions, we are seeking partnerships with others to enable change and maximize impact (Goal 17).
Who We Are
A highly specialized pharmaceutical company that has conducted neuroscience research for more than 70 years. We develop innovative treatments to restore brain health and transform the lives of millions of people worldwide.
What We Strive For
Global leadership in brain health. Whatever your area of specialization, you will be part of our company-wide commitment to develop and advance treatments that improve the lives of people with brain disease.
What Drives Us
A culture of innovation, collaboration, and respect. We inspire curiosity, expect integrity, and pursue our achievements through knowledge-sharing, patient engagement, and the passion to deliver our end goal.
Our Societal Commitment
We understand we carry a huge responsibility for the societies we serve, and use our knowledge and voice to raise awareness, challenge standards, and increase opportunities – for patients and each other. We are at the forefront of treatment innovation, and together we continue to make a difference to people living with brain diseases.
Our Investment in You
As one way we invest in your career, we offer our employees a competitive compensation and benefit package that matches benchmark and general market conditions in our individual business locations.
The success of our strategy, “Expand and Invest to Grow Lundbeck” hinges on our combined competencies – and competence hinges on highly qualified and motivated employees. Our Employee Satisfaction Survey (ESS) gives us the pulse on employee motivation by asking about key elements in our work lives including management, work climate and development opportunities. We follow up on the ESS with concrete initiatives aimed at maintaining our focus on our unique workplace culture and providing personalized and aligned development opportunities for our employees.
• Patient-driven We put patients at the center of our fight for health and human dignity.
• Courageous We dare to confront unsolved healthcare challenges.
• Ambitious We set high expectations for ourselves because people in need have high expectations of us.
• Passionate We persist in developing life-changing therapies because life should not be interrupted by brain disease.
• Responsible We act with respect and integrity in everything we do
6 Parkway North
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