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Associate Clinical Project Manager

Req ID:  661

Working Location: MASSACHUSETTS, SOUTHBOROUGH 

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. 
 
Let’s inspire healthier lives, together.

Job Description

The Associate Project Manager (APM) is a critical member of the Clinical Affairs team, responsible for providing clinical guidance, strategy and support for new technologies and current products including clinical value proposition development. APM assists in the design, development, organization, implementation, evaluation, and publication of scientifically valid clinical research. Serves as the clinical representative on product development teams, providing clinical support to cross-functional colleagues (marketing, R&D, RA, etc.). Effectively coordinates the activities of clinical research team members and investigators, and ensures compliance with study protocols, applicable regulations, guidances, policies, and procedures.

Job Duties

* Lead pre- and post-market clinical trials in line with business objectives

 

* Serves as Clinical Study Project leader and/or Clinical Affairs representative on assigned project teams and/or Product Development Process  teams to provide clinical guidance, strategy, and support for the development of new technologies, new products, and extended product claims

 

* Maintain responsibility for managing clinical study activities and site management for multiple clinical sites for several ongoing clinical studies

 

* Maintain responsiblity for developing clinical project budgets utilizing fair market value tools

 

* Tracks progress of clinical studies with regard to budget, study milestones, and deadlines; clearly communicates study updates to management on a regular basis

 

* Maintain responsibility for managing project-specific vendors 

 

* Assist in the development of best practices for study management 

 

* Designs and develops key clinical study documents (e.g. informed consent forms, study specific plans, study master file plan) and participates in preparation of data management plan 

 

* Participates in site start-up activities including creation and shipment of the investigator site file, collection of essential regulatory documents, and IRB submission(s)

 

* Conducts monitoring visits as necessary in compliance with the study specific Monitoring Plan, Standard Operating Procedures, Good Clinical Practices (GCP) and applicable government regulations and guidelines; ensures site compliance to protocol, reviews investigator site file, performs source document verification (SDV), query resolution, and documents adverse events

 

* Conducts monitoring visits as necessary in compliance with the study-specific Monitoring Plan, Standard Operating Procedures, Good Clinical Practices (GCP) and applicable government regulations and guidelines; ensures site compliance to protocol, reviews investigator site file, performs source document verification (SDV), query resolution, and documents adverse events

 

* Communicates clearly with clinical sites; authors and/or reviews monitoring reports, follow-up letters, study memos, and general correspondence

 

* Performs comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature required to support assigned product lines and related clinical studies

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor's degree required. Bachelor's degree in a related field (e.g., biological, medical, public health, physical sciences, engineering) preferred

 

* Minimum of 3 years experience conducting clinical research in the medical device/biotech/ pharmaceutical industry

 

* Ability to travel domestically at least 20% of the time

 

* Ability to travel internationally up to 10% of the time

 

* Overnight trips domestically and internationally should be expected

 

* Multiple days on site may be necessary

 

* Willingness to sometimes work during off-hours due to global responsibilities

 

PREFERRED QUALIFICATIONS:

 

* Strong knowledge, understanding and application of principles, concepts and practices of clinical studies

 

* Working knowledge of clinical trial regulations, standards and Good Clinical Practices

 

* Solid understanding of scientific/clinical research

 

* Strong analytical skills

 

* Detail oriented and well organized

 

* Ability to independently set and manage multiple priorities

 

* Ability to work effectively on a cross-functional team

 

* Advanced user of Microsoft Office applications (Word, Excel, Project, PowerPoint)

 

* Experience with electronic data capture (EDC) systems

 

* Experience monitoring clinical studies preferred

 

* Basic understanding of statistics, statistical, methods, and study design preferred

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.

Olympus…True To You. True To Society. True To LIFE.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Massachusetts (US-MA) || Southborough || 

 

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