Company Description
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 Description
The Area SSU Lead is responsible and accountable for on-time, budget and quality delivery and execution of the start-up and maintenance activities of the assigned pipeline and Global Medical Affairs clinical studies within area. The role reports into the Area SSU Head and serves as a single point of accountability across the area for the delivery and execution of the site start up and maintenance activities for the assigned studies within the area. Area SSU Leads will report into the Area SSU Head but have an operational reporting line to Global SSU Leads. In the US, Area SSU Leads will report in through Area SSU COMs, who report to the Area SSU Head.
- Overseeing and proactively driving activities of Country SSU Specialists for assigned trials. Proactively identifying and communicating issues impacting delivery and providing proposed solutions. Working with Area and Country leadership to identify training needs of the country start-up specialists and standardizing and facilitating training solutions for Start-up specialists within area.
- Accountable for on-time, budget and quality delivery and execution of the start-up and maintenance activities of the assigned clinical studies within area. Working collaboratively with key stakeholders and establishing country/site activation plans including risk assessments and mitigation planning for the countries and sites within their area.
- Building country level ICF samples, reviewing IRB/EC comments on ICFs and routing for approval by required functional areas (as required by region). Driving start up activities including timely site selection and activation, EC submissions, document collection, and query responses.
- Providing area start up updates and metrics to Area Director, and Global SSU Leads. Running area start up meetings and driving priority action items between meetings. Collaborating with Global Site Contracting & Purchasing and Supplier Management, CTS and Regulatory Affairs, Global SSU Leads, Global CSM Leads, Country COMs and Country SSU Specialists to assure alignment between contract execution, CA and EC submission activities, site training visits and site activation planning.
- Leading quality management through risk-based thinking for the assigned studies. Driving standardization in area start up process and training, including sharing of best practices and lessons learned. Maintaining SSU performance metrics and KPIs for assigned studies.
- Ensuring audit/inspection readiness. Ensuring maintenance of intelligence database and Vault EDLs for countries and sites within their area.
- Ensuring compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines. Participating in process improvement initiatives as required.
Qualifications
- Bachelor’s degree in health care or scientific field highly preferred, or equivalent years of experience required
- A minimum of 6 years of clinical research experience and preferably 4+ years of study start up management experience for the designated region. Must have hands on experience in interpreting regional clinical research regulations and processes.
- At least 2 years of experience in line management of people, coaching and mentoring of staff and teams preferred.
- Preferred exposure in study initiation through study completion in multiple phases of studies (Phase II and III, Phase I in patients).
- Proven leadership skills in a cross-functional global team environment, experience in working with remote/virtual teams, and an ability to influence and align stakeholders in a cross-functional, multi-cultural environment.
- 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 and communicate persuasively and with clarity, flexibility, and adaptability to changing requirements.
- Demonstration of successful program execution, preferably in start up, and aptitude for managing multiple priorities in a fast‐paced environment.
- Demonstration of participation in successful initiatives, special projects, and activities that support the business.
- Advanced working knowledge of ICH and GCP guidelines and operational understanding of the area regulatory environment.
This is a remote opportunity based out anywhere in the US
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.
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 an equal opportunity employer and 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.
US & Puerto Rico only – to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Read Full Description