Purpose

Describe the primary goals, objectives or functions or outputs of this position.

Advance Abb Vie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging advanced capabilities to drive industry leading performance.

Partners with study teams, Abb Vie internal R&D stakeholders, investigators, and site staff for meaningful and effective engagements positioning Abb Vie as the partner of choice in clinical trials.

Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.

Responsibilities:

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

"Considered as the Pprimary Sponsor p Point of contact for the investigative site. Advanced level of competency or experience in providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening Abbvie's positioning.

• Ability to motivate and align monitoring community through leadership and mentorship."- Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership. Able to support, guide, and mentor junior personnel on Site Management activities.
• "Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, Abb Vie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
• Superior understanding of site engagement and ability to customize site engagement strategy for assigned study/ies and critically apply new strategies as needed. Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategy.
  Superior level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Expert understanding to generate and ensure effective recruitment and retention techniques/plans based on the patient disease journey.

Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance."- Possesses advanced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. Supports local onboarding of more junior CRAs. Demonstrates ability to openly listen to and consider viewpoints to enhance outcomes.
May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager.

"- Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. Superior ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a cust

• Independently Identifies, evaluates and recommends new/potential investigators/sites on an on going basis demonstrating expert understanding and decision making. Potential sites may be identified through networking or internal Abb Vie requests to assist in the placement of planned clinical studies with qualified investigators.
• Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Ensures audit and regulatory inspection readiness at assigned clinical site at all times. Manages investigator payments as per executed contract obligations, as applicable.

Qualifications:

List required and preferred qualifications (up to 10). Include education, skills and experience.

• Appropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred.
• Minimum of 3 years of clinically related experience, of which a period of 2 years is preferable in independent clinical research monitoring of investigational drug or device trials in any therapeutic area. Familiar with risk‐based monitoring approach, onsite and offsite monitoring.
• Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials
• Superior knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
• Demonstrate advanced communication skills and superior cross-functional collaboration skills among internal and external stakeholders.
• Demonstrate superior planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
• Superior ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
• Superior interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
• Ability to independently use functional expertise, leverage critical thinking skills and apply good judgement to address clinical site issues
• Acts with integrity in accordance with Abb Vie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.

Abb Vie setzt sich für Chancengleichheit ein und verpflichtet sich, mit Integrität zu arbeiten, Innovationen voranzutreiben, Leben zu verändern und unserer Gemeinschaft zu dienen. Chancengleichheit bei Arbeitgeber/Veteranen/Behinderten.

Über Abb Vie

Abb Vie ist ein globales, forschendes Bio Pharma-Unternehmen. Unsere Mission ist es, innovative Therapien zu erforschen und bereitzustellen, um die medizinischen Herausforderungen von heute und morgen anzugehen. Abb Vie will einen echten Unterschied im Leben der Menschen machen – über verschiedene Therapiegebiete hinweg: Immunologie, Onkologie, Neurologie, Augenheilkunde und Virologie sowie mit dem Portfolio von Allergan Aesthetics in der medizinischen Ästhetik. In Deutschland ist Abb Vie an seinem Hauptsitz in Wiesbaden und seinem Forschungs- und Produktionsstandort in Ludwigshafen vertreten. Weitere Informationen findest du unter www.abbvie.de. Folge @abbvie_de auf X oder besuche unsere Profile auf YouTube oder LinkedIn. Unter www.abbvie-care.de findest du umfangreiche Informationen zu den Therapiegebieten, in denen Abb Vie tätig ist.