ABBVIE Ludwigshafen Germany
2 weeks ago
Welcome to AbbVie! As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity to work closely with us to address the health challenges of tomorrow. Do you have a passion for improving health care around the world and for using your expertise to improve patients' quality of life? In a challenging work environment that allows you to broaden and develop your own skills? You’ve found the right place!
AbbVie Clinical Data Strategy and Operations (CDSO) is the best-in-class team within its cross-industry peer group. We are 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 delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences.
Further develop your expertise and join our team... as
Program Data Manager II
Make an impact:
With a lot of experience and even more passion, you will be joining our team in Ludwigshafen am Rhein.
• Uses understanding of clinical trial concepts and cross-functional protocol requirements to execute assigned study assignments.
• Engages with members of the CDSO and cross-functional study teams in order to effectively execute assigned activities.
• Lead clinical study team in the development of key clinical trial systems, study conduct and study close-out as related to Clinical Data Strategy and Operations (CDSO) operational activities. Create and manage Data Sciences communications plan for all assigned clinical trials. Exercises real, but informal authority over CDSO study team members’ daily tasks and timelines.
• Effectively utilizes available technology to execute assigned activities; Deep knowledge about EDC System (RAVE Architect, Veeva) are required.
• Utilizes data standards (CDASH and SDTM) and protocol requirements in the design and development of key system interfaces and end-to-end data flow.
• Oversee the production of all Data Sciences timelines and deliverables for assigned clinical trials and all DSS-related cross-functional meetings with clinical teams, safety teams and physicians
• Creates study execution documentation including specifications, data management plan, and integrated data review plan. Executes data management plan and integrated data review plan as required by protocol and team decisions.
• Triages issues as they occur and maintains required documentation per ALCOA principles. Performs data review using supplied data review tools. Performs reconciliation of data originating from different sources. Queries clinical sites as necessary to clarify possible data abnormalities.
• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development. Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Participates in CDSO and cross-functional innovation and process improvement initiatives
• Aligns CDSO study teams with study-level strategies. For assigned studies, leads the CDSO Study Team and represents CDSO as a member of the cross-functional study team.
• Lead clinical study team in the development of key clinical trial systems, study conduct and study close-out as related to Clinical Data Strategy and Operations (CDSO) operational activities. Create and manage CDSO communications plan for all assigned clinical trials. Exercises real, but informal authority over CDSO study team members’ daily tasks and timelines.
• Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, to track study progress. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions.
• Responsible for all CDSO project activities for in CDSO for all assigned trials.
This is how you can make a difference:
• Bachelor’s (Master’s preferred) degree in business, management information systems, computer science, life sciences or equivalent.
• Must have at least 6+ years of pharmaceutical, clinical research, data management, health care or other relevant experience.
• Strong understanding of clinical trial processes and clinical technology.
• Demonstrated history of successful execution in a fast-paced environment and in managing multiple priorities effectively
• Demonstrated effective problem-solving and analytical skills
• Demonstrated strong leadership traits and the ability to coach/lead in a matrix environment
• Demonstrated strong leadership competencies with broad business orientation and experience in leading teams in the management and completion of clinical trials
• Strong understanding of GCDMP
What we offer you:
• a diverse area of work where you can make a real difference
• an open company culture
• attractive remuneration
• intensive onboarding by a mentor
• flexible work models for a healthy work-life balance
• corporate health management with comprehensive health and exercise programs
• corporate social benefits
• diverse career options in an international organization
• high-level, attractive career development opportunities
• a strong international network
At AbbVie, your individual contributions count – help us achieve more together. Be a part of it and grow with us – go above and beyond!
Sounds like the perfect career opportunity for you? We look forward to receiving your application. All you need is a complete CV – anything else will be discussed in person, where possible, if general suitability is determined.
Have questions? Email us at Talent[email protected] – we look forward to hearing from you!
AbbVie is an equal opportunity employer including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours
Program Data Manager II (all genders) - (permanent / fulltime) Ludwigshafen jobs
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