Clinical Project Manager/Project Manager/Study Lead - Medical Devices
Hollister Incorporated - Libertyville, IL
January 16, 2018
Libertyville/Chicago northern suburbs, Illinois
Full Time - Experienced
Academic / Research
4 Year Degree
Hollister Incorporated is looking a Clinical Project Manager, who will be responsible for the execution of clinical studies and ensure that they are carried out consistently with Hollister's business strategies. This is a high-visibility role and this individual will interface with and report study progress to Sr. Clinical Management and business unit/corporate management. This talented individual will also interface with key business stakeholders across several functions, including Marketing, Regulatory, Market Access, R&D, Clinical Operations, Clinical Data Management and Statistics. He/she will develop good working relationships with clinicians (physicians and nurses), other external research staff and external vendors. He/she will be responsible for planning medical device studies, and coordinating execution efforts for assigned studies both within Hollister and through a variety of vendors. This is an exciting opportunity for someone who wants to grow and lead, at a company that appreciates talent and initiative! Come join our team and make a difference!
With minimal supervision, plans and manages global clinical trials/studies within agreed-to budget, scope and schedule/timeline requirements. Will be responsible and accountable for several concurrent clinical studies.
Uses project management tools (including new ideas you may bring) to build and communicate accurate study timelines and budgets.
Executes high quality, integrated cross-functional plans for the clinical study/trial.
Responsible for the execution of a clinical trial or suite of clinical trials from clinical protocol design to the final clinical study report.
Provides study updates to senior clinical management and to business unit/corporate management.
Understands assigned study protocols and study data.
Actively tracks study data analysis and publication activities.
Ensures completion of timely clinical study reports for use by business world-wide (both internal and external customers: e.g., core teams, discovery teams, and regulatory submissions).
Leads development of clinical study protocols along with clinical management and reviews/approves supporting documentation.
Supports strong relationships with study sites and clinicians. May review reports and support resolution of issues related to external sites as needed in support of clinical study activities.
Leads clinical affairs team collaboration with business units and functional departments as well as collaboration within clinical affairs team (clinical operations, clinical experts, clinical data management and statistical team).
Ensures regular review, summary and reporting of accurate clinical study progress to gatekeepers/stakeholders, project teams, regulatory and marketing teams throughout the course of a study.
Contributes to relevant study documentation including clinical protocols, case report forms and clinical study reports.
Proactively identifies study risks and works to mitigate them or create contingency plans.
Sitting for extended periods of time.
Dexterity of hands/fingers to operate a computer keyboard, mouse, and other devices and objects.
Physically able to participate in and lead planning sessions, training sessions, presentations, and meetings.
B.S. degree (relevant to position) and a minimum of 5 years of relevant (PM or cPM) experience
PMI (Project Management Institute) certification a plus
Specialized Skills/Technical Knowledge:
Clinical project management track record with a working knowledge of project management tools and best practices (e.g., Microsoft Project, other)
Excellent communication skills, both written and verbal
Ability to progress a study with minimal guidance; Initiative and drive for results
Experienced in managing global clinical trials and in leading a clinical study teams
Experience in (or strong interest in) Medical Devices a plus
Demonstrated understanding of creating and communicating an accurate clinical budget
Demonstrated ability to collaborate and interact effectively on a cross-functional team (represent Clinical Affairs)
Organizational, leadership, risk identification and problem solving skills
Experienced in protocol development, study management, and study reporting
Demonstrates an interest in and understanding of clinical developments and trends
Telecommuting is allowed.
Internal Number: 24361
About Hollister Incorporated - Libertyville, IL
For over 90 years, Hollister Incorporated has built a strong foundation of quality medical products, quality services, and quality employees - making a difference in the lives of those we serve. Hollister Incorporated stands strong: We are an independent and employee-owned company. Committed to our customers. Dedicated to our employees. Working towards the future with a long-term vision.
Our challenge at Hollister Incorporated is to find those who share this dedication of helping others. Those searching for a way to make a difference. To leave a legacy of achievement. Knowing it takes talent, teamwork, and sheer determination.
Hollister Incorporated is a company where dedicated professionals can channel their efforts in a worthwhile cause. A company where good work is rewarded. Where contributing selflessly is highly regarded. This growing global medical device company will make the journey...with you. So join us, and make a difference.