Date: May 13, 2022
Location: Congers, NY, US, 10920
Company: Aptar Group
CLINICAL PROJECT LEADER
Create, Innovate, Deliver Solutions! This is what you can expect from a career Aptar Pharma Digital Health. We have an exciting opportunity for a Clinical Project Leader, Digital Health reporting into the Chief Medical Officer. If you are curious, self-motivated and eager for new challenges, we are the next step in your career! Be Aptar!
Aptar Pharma Digital Health offers a broad range of sophisticated digital healthcare solutions, which are patient friendly, easy and intuitive to use. Our digital healthcare solutions are available for the prevention, diagnosis and treatment of diseases, as well as patient monitoring and health management. Aptar Digital Health is part of Aptar Pharma and Aptar Group, ticker symbol ATR. Aptar Pharma is a leading provider in drug delivery medical devices along with digital health solutions to improve patient care.
What You Will Do at Aptar Digital Health
The Clinical Project Leader (“CPL”), plays an important role in the clinical trials process from concept to clinical study report completion. The CPL performs a wide variety of activities to manage clinical trials and conduct clinical operations according to the clinical plan and company strategy. The CPL is the primary contact with targeted medical centers, investigators, research organizations, external vendors as well as Aptar Digital Health medical affairs & associated teams. This position is primarily focused on US studies in close collaboration with teams in US and in France to achieve goals. The primary responsibilities are to support the development and execution of payor value and market access strategies for pharmacos’, providers’ and payors at a global or regional level and by:
- Manage all deliverables per project meeting deadlines, budgets and key milestones.
- Assesses the operational feasibility of clinical trials and recommends execution and risk mitigation plans.
- Leads the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, and case report form design.
- Drives CRO and other vendor selection, budget and contract negotiation and management.
- Identifies clinical trial sites and investigators in collaboration with the medical affairs team and ensures appropriate clinical resources are available for the clinical trial in the selected center(s).
- Develops and tracks study timelines, deliverables, budget, quality metrics, and generates routine reports. Ensures that study objectives are met through setting project priorities and milestones. Proactively identifies and resolves issues and participates in process improvement initiatives as required.
- Identifies and coordinates with the Digital Health internal team assuring project timelines and budget are met. Coordinates internal activities including securing data processing and data exchange agreements.
- Ensures GCP and regulatory compliance is maintained.
- Manages activities and communication with external CRO, vendors and study sites including the review and approval of invoices. Organizes and leads meetings with investigative sites, key opinion leaders and consultants as needed.
- Responds promptly and appropriately to study questions and issues raised by investigative sites, vendors, monitors, and consultants.
- Evaluates monitoring reports with significant findings to confirm appropriate conclusions and actions are taken.
- Participates in the analysis, summary, and reporting of clinical data throughout the course of the study.
- Provide pre and post market support ensuring customer requirements are understood; product and programming designs meet deliverables.
- Maintains and updates the Digital Health clinical quality system (SOP/WI) and its related trainings.
- Maintains professional expertise through familiarity with therapeutic area and clinical research literature.
- Manages, mentors, and develops direct reports (if any).
- Aides in the training and development of all clinical staff members.
- Performs other duties as assigned.
What Aptar DIGITAL HEALTH Is Looking For
- At least 5 years clinical research experience in an industry setting and a minimum of 2 years project-lead or management experience.
- Prior experience with medical devices and/or managing Phase III clinical studies is desired. Experience in oncology studies is preferred.
- Bachelors and/or master’s degree in a scientific discipline, RN, BSN or equivalent. CRA certification (ACRP or equivalent) is strongly preferred.
- Conscientious, influential person with an outstanding work ethic and strong personal discipline.
- Excellent organizational, leadership and problem-solving skills. Must be able to manage multiple projects and timelines.
- Excellent written and verbal communication skills. Prior experience in writing clinical study documents required.
- Experience in leading cross-functional teams to meet goals and metrics.
- Experience with budget development, negotiations and monitoring.
- Proficient computer skills, specifically with Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook). Working knowledge of MS Project for development and update of clinical study timelines required.
- Must possess a solid understanding of FDA and other regulatory requirements that impact US medical device studies as well as have a thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
- Ability to travel approximately 10%
- Excellent Microsoft Word, PowerPoint, and Excel skills.
- Fluency in oral and written English is required. Multiple language skills is a big plus!
What We Offer
- An exciting, diverse and value based working environment
- Award-winning corporate university offering personal development and training opportunities.
- Competitive base salary
- Contribute to the communities where we reside.
- Innovative benefits plan which includes: 401k plan with Company matching benefit, paid time off, medical, dental, vision, life, disability and more
BE YOU, BE APTAR!
Aptar is an Equal Employment Opportunity (EEO) employer. We believe that a diverse workforce is key to our success. We welcome applications from all members of society irrespective of age, sex, disability, sexual orientation, race, religion or belief It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information
Aptar Pharma, NA
Nearest Major Market: New York City
- Address Congers, NY, USA
- Salary Offer $100.000 ~
- Experience Level Senior
- Total Years Experience 5-10