Sr. Manager, Clinical Development
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
The Sr. Manager Clinical Development – Aesthetics is responsible for coordination and management of all aspects of clinical studies, including protocol development, regulatory compliance and vendor management. The position is responsible for leading department activities related to clinical processes and procedures. Contributes technical and clinical operations expertise.
- Lead development of clinical protocols as well as informed consent forms, case report forms, clinical study reports, annual reports, various study materials, and monitoring tools.
- Lead activities related to clinical trial vendor management including selection, contracting and ongoing oversight to ensure successful outcomes.
- Liaise with internal stakeholders to develop and streamline departmental operating procedures.
- May coordinate the activities of relevant colleagues within the Company and Investigators to ensure compliance with the overall scientific study objectives.
- Develop and maintain clinical data summaries and analyses and presents data for inclusion in regulatory submissions and/or other company uses.
- Act as lead on assigned projects.
- Process and apply specific knowledge to the completion of difficult work assignments.
- Perform monitoring activities.
- Assure regulatory compliance in trials as well as compliance with corporate SOPs
- Tracks patient recruitment, produce status reports and monitoring reports, track SAEs, conduct study close-out activities, conduct query resolution, and other duties associated with monitoring and managing clinical studies.
- Aids in setting the strategy, budget, and goals for the clinical department.
- Provide training for company and clinical site staff through formal presentations.
- Function as mentor and role model for other clinical team members
- Maintains a high level of professional expertise and follows all procedures related to this job that can affect the quality of products or services provided to our customers.
- Bachelors degree in a scientific discipline or related field required.
- Minimum 6 years of related clinical trial management experience.
- Proven track record of successful clinical study management.
- Ability to focus on and achieve scheduled milestones, including contingency planning.
- Good clinical knowledge with an understanding of medical terminology.
- Knowledge and understanding of ICH GCP guidelines and FDA regulations related to clinical studies.
- Strong team-working and communication skills. A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.
- Competent using office software including MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
- Up to 40% (or more) domestic and international travel may be required.
Significant Work Activities
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Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.