AbbVie Area Head, Area Study Start Up and Area Site Management in Poland
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 (https://twitter.com/abbvie) , Facebook (https://www.facebook.com/AbbVieGlobal) , Instagram (https://www.instagram.com/abbvie/?hl=en) , YouTube (https://www.youtube.com/user/AbbVie) and LinkedIn (https://www.linkedin.com/company/abbvie) .
The Area Head, Area Study Start-up and Site Management reports into the Clinical Site Management (CSM) Area Director and is responsible for overall leadership and management of the ASUL and ASML team, processes, and clinical programs execution and CSM deliverables in in their assigned geographic Area. They will connect the strategy and direction outlined by the Global Site Management Lead (GSML) and Global Start-up Lead (GSUL) with the ASML's and ASUL's and ensure global process consistency and alignment across the studies in the area.
The primary focus of this position includes optimal resource management planning for the ASML and ASUL team, overseeing proactive planning for study start-up, recruitment and retention of subjects, data base lock and study closeout activities; as well as, oversight to ensure high quality study oversight and monitoring performance. Driving the expectation of quality and compliance throughout the process. They will liaise with other Area Heads, Area Site Management and Area Start-up Leads to ensure consistency in ASML and ASUL processes and training.
Primary responsibilities include but not limited to:
•Build and maintain a high performing ASML/ASUL team, ensuring alignment cross CSM department
•ASML/ASUL resourcing, integrity of practices, quality, and timeliness of ASML/ASUL deliverables within the geographic area including driving standardized ASML/ASUL processes, issue escalation/mitigation, Adaptiv risk-based quality management thinking, assist with inspection readiness, as needed, across all studies within the AbbVie portfolio in the area to ensure on-time and on-target quality CSM deliverables.
•Responsible for strategizing, planning, directing, and coordinating Clinical Site Management (CSM) activities within the area ASML/ASUL team.
- Provide start up focused strategic input on the area and country strategy, start up timelines, site profiles and risks assessment for the Area. Establish country/site activation plans including risk assessments and mitigation planning for the Area
-Manage identified risks to study start-up/conduct through development of effective mitigation plans
•Ensure ASML/ASUL timelines and accountabilities for site selection, driving recruitment, study maintenance and deliverables are successfully attained.
- Drive maintenance of country and site intelligence for assigned area
•Ensure consistency of customer service and processes across the ASMLs. Partner with other Heads, ASMLs/ASULs in other areas to ensure consistency.
•Line Management and development of ASML Managers and ASULs in the area.
•Supervise and oversee management of resources, hiring, training, growth, and development of ASML/ASUL team. Maintain ASML/ASUL training curriculum and advise on ASML/ASUL training and development needs.
•Serves on the Area’s Senior Leadership Team of the respective Area Director.
•Provide regular area/country level updates on CSM deliverables, metrics, and resource utilization to Area/Country Leadership and GSML/GSUL, as appropriate.
•Drive a learning environment (best practice sharing and lessons learned) within area.
•Collaborate with cross-functional teams and Contribute to ongoing process improvement initiatives within the area.
•Assist the ASML/ASUL Team in proactively communicate and planning with Country teams (COM / CCOM) the CSM resources in alignment with the study deliverables and milestones.
•Craft annual ASML/ASUL performance goals and targets to ensure alignment across ASMLs/ASULs, GSML/GSUL and Area.
•Maintain knowledge of ICH/GCP, regulatory requirements, AbbVie SOPs, therapeutic area (protocol, amendments). strategy, and delivering on global monitoring execution plans.
•Clinical Site Management (CSM), Contract Management Group •Clinical Study Leadership (CSL) •PIR •Central Development Services (CDS) •Global Medical Affairs (GMA) •Therapeutic Area Medical Directors (TA MDs) •DSS •CDSM, Clinical Trial Submissions Group, Legal, Safety, OEC
•Bachelor's Degree required, degree in health care or scientific field preferred.
•Minimum of 12 years of clinical research experience, with 6+ years of relevant study leadership and people management experience
•Proven leadership skills in a cross-functional matrix environment, experience in managing remote/virtual teams, and an ability to influence and align stakeholders, while modeling and driving AbbVie’s Way We Work attributes.
•Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives and drive smart decision making. Excellent interpersonal skills with the ability to build trust, communicate with influence and clarity, flexibility, and adaptability to changing requirements.
•Expertise in drug development, operations, risk-based thinking, and resource planning
•Demonstration of successful study execution/staff oversight and aptitude for managing multiple priorities in a fast‐paced environment.
•Advanced working knowledge of ICH and GCP guidelines
Yes, 15 % of the Time
Job Level Code
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.