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Senior Manager, Clinical Data Systems
1 month ago
AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job DescriptionPurpose:
AbbVie Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is a key to ensuring successful Data collection systems delivery against the program and study-level accountabilities.
Description:
Provides technical project management leadership, support, and influence to ensure timely and quality clinical technology deliverables across data collection and processing systems such as Electronic Data Capture (EDC), Interactive Response Technology (IRT), Electronic Clinical Outcome Assessment (eCOA) , Clinical Photography/Imaging, Clinical Data Repository (CDR).
- Leads and manages the full lifecycle of systems developed internally or by the external vendors for individual clinical trial use.
- Managing the design, development, validation, implementation, and overseeing ongoing support to these systems.
- Support in the validation of electronic clinical technology systems as implemented throughexternal vendors or developed internally according to current regulatory requirements.
- Supports development and implementation of departmental Standard Operating Procedures (SOPs) and work practices.
- Provides leadership and content expertise for system development activities from start-up through the statistical analysis stage of clinical studies to effectively manage data capture, review, and database lock activities.
- Other responsibilities include providing strategic input into the analysis of new systems and software to support clinical trials data collection, quality, and integrity.
- Support inspection readiness activities, as well as participate in sponsor and site inspections.
- Responsible for hiring, training, and managing performance of staff (inclusive of orientation, personal development, completing and administering performance evaluations, reward and recognition). Ensures timely hiring of qualified resources. Actively promoting empowerment and accountability within staff.
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Qualifications*This position will be required to sit on-site 3 days / week*
- Bachelor’s degree in business, statistics, management information systems, computer science, life sciences or equivalent is required. Master’s degree is desired.
- 4+ years of experience in clinical development in pharmaceutical or related industry
- Experience managing matrixed project-based personnel and/or direct reports
- Experience in clinical data management processes and systems
- Experience managing vendor relationship incl. governance and KPI/SLA tracking.
- Demonstrated effective communication, analytical, and leadership skills
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.
