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Clinical Project Manager

Req ID:  2016

Working Location: WASHINGTON, REDMOND 

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 Manager, Clinical Projects is responsible for the execution of a clinical trial from completion of the protocol design to the final clinical study report; responsible for safety reporting for all Olympus Redmond clinical studies and provides clinical support and strategies to support business objectives including achieving clearances and approvals in the US and internationally. This role includes oversight and management of clinical project personnel and/or consultants. The Manager, Clinical Projects may be responsible for multiple clinical studies.   

Job Duties

* Management – Responsible for all SVS studies Olympus Redmond studies, from inception through completion.

 

* Monitoring - Assures compliance with monitoring intervals according to the project requirements. Develops action plan and guidelines. Initiates and trains sites to the study protocol to ensure proper site adherence to clinical research regulations. Serves as a mentor to Spiration clinical field specialists.

 

* Communication - Maintains timely and effective communication among team members. Attends kick-off and update meetings. Ensures appropriate documentation of project meetings.
Oversight - Reviews the study scope of work, timeline, budget (as applicable), and protocol content. Collaborates with internal project team members to assure timely initiation process.

 

* Analysis– Identifies areas of best practice and process improvements. Optimizes the pre-screening and screening process at all of the study sites to meet enrolment goals. Optimizes the process for increasing referrals from physicians who treat patients that may meet study enrolment criteria. Optimizes the utilization of Clinical Field Specialists and CRO’s to meet study objectives. Identifies areas of best practice and process improvements

 

* Interface – Maintains excellent rapport with internal staff and external health care providers and business associates. Communicates continuously, in a timely fashion, documents communication with the CROs, clinical site coordinators, investigators, core support labs, and other study staff as directed by protocol(s) and clinical requirements. Directs interface and communication with Spiration management and staff and Olympus affiliate staff involved in OUS clinical studies.

 

* Safety – Manages AE databases for all Olympus Redmond clinical studies, coordinates safety reporting with Regulatory and Quality, coordinates  safety committees,(i.e.; CEC, DSMB, etc)  

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor's degree in health sciences, medical science, or scientific field required. Additional education in project management preferred.

 

* Minimum of 8 years experience in the clinical research field. 2+ years in a lead, or project management role also required. Experience in the field of respiratory or interventional pulmonary medicine highly desired.

 

PREFERRED QUALIFICATIONS:

 

* Knowledge of clinical research (helpful if background is in respiratory, pulmonology and/or thoracic surgery).

 

* Proficient skills with project management tools and techniques.

 

* Comprehensive understanding of regulations applicable to clinical research, including Thorough understanding of Good Clinical Practice guidelines and applicable FDA other regulatory body requirements.

 

* High level of proficiency in Microsoft Word, Outlook, Excel and PowerPoint required. Visio skills desirable. Experience with electronic clinical systems (eTMF, eCTMS, EDC).

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) || Washington (US-WA) || Redmond || 


Nearest Major Market: Seattle
Nearest Secondary Market: Bellevue

Job Segment: Project Manager, Manager, Technology, Management

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