Advanced Clinical Hiring for Senior Supply Manager Job at Dublin , Ireland Full Time

***This position can be worked remotely from anywhere in Europe but ideally in Ireland***

The Senior Supply Manager is the leadership role for overseeing and performing operational activities of Clinical Supply Management (CSM) for Phase I-III global clinical trials. A qualified candidate with the knowledge of the industry, regulations and supply chain & logistics will be in client facing role for ensuring and building operational efficiency by creating an adaptable optimization strategy for the client. Collaborate with leadership for creating and performing trainings and mentorship to the team for excelling the CSM operations and planning.

Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there’s no better place to grow your career than Advanced Clinical.

Responsibilities

• Own client relationship by supporting project as a primary contact for Supply Management.
• Lead operations for all the activities to drive Clinical Supply management (CTSM) services including management of IP, Ancillary material and Lab services to ensure project objectives are met on budget on time.
• Ensure the requirements for Supply Management at project level are met the need of the sponsor, including forecasting and planning.
• Support strategic sourcing and procurement of materials for supplies including commercial drugs at global level.
• Define IP handling strategy and perform IP calculation in study start-up.
• Assist in serving as author of Supply, Depot and Pharmacy manuals.
• Manage CTSM outsourced vendors contracts, purchase orders, and invoice accuracy.
• Assist in defining the specification of electronic management systems such as RTSM/IRT. Additionally, contribute to the User Acceptance Testing and implementation and ensure maintenance of the clinical supply management system(s) as daily activities.
• Serve as a liaison between vendors and sponsors for planning and maintaining all operational aspects of assigned projects including sourcing, packaging, labeling, storage, distribution, and destruction of materials
• Establish and maintain an effective communication for material (IP and ancillary) management such as inventory, expiry dates, temperature excursions and reconciliation.
• Support Regulatory and QA requests for CTM documentation and audits.
• Participate in team meetings and internal management calls to provide updates on operational activities, revenue and resource allocation.
• Participate in internal and external audits and SOP reviews on as needed basis.
• Prepare product demonstration materials (e.g. video, slide decks, etc.) for investigator meetings, training sessions and advisory boards.

Qualifications

• Bachelor’s or master’s degree or higher strongly preferred.
• 5+ years of experience supporting clinical research, including CRO/industry experience in all phases of clinical research, supporting US as well as international trials with minimum of 2-3 years of supply management experience.
• Knowledge of pharmaceutical and regulatory requirements, procedures, and policies
• Familiarity with drug product terminology, including investigational drug, comparators and ancillary supplies.

Role Competencies

• Individual who has leadership skills and can work independently to help a project or company progress.
• Ability to train and mentor team and guide to resolutions.
• Ability to analyze information, review reports and prioritize actions.
• Ability to competently manage a heavy workload and multiple competing priorities, switching priorities quickly as needs change. Must be comfortable working in a quick-paced environment.
• Demonstrated exceptional interpersonal skills and written and verbal communication abilities.
• Global perspective and mindset; ability to work effectively in cross cultural and global environment.
• Ability and willingness to travel up to 25%.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Group in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity

It is Advanced Group’s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.

This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.