Associate Clinical Study Manager

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General Summary 
Provides leadership in the planning, design, and execution of clinical studies sponsored by Penumbra to assess safety and effectiveness of products. This position works with confidential subject and company data, and interfaces with a variety of internal and external stakeholders.  We are currently open to candidates located anywhere in the continental US, provided they meet the qualifications below.

Specific Duties and Responsibilities 
Develops/maintains project timeline inclusive of startup through completion (e.g., database build, data snapshots for study reports, abstracts, manuscripts, DSMB, CEC meetings, and regulatory submissions) * 
Drives development, approval, and distribution of study-related documents and study tools for investigational sites and review committees as directed by management. * 
Manages distribution, collection and tracking of regulatory documentation to help ensure audit readiness at both the sites and Penumbra headquarters. * 
Negotiates study budgets with sites, Core Labs, and other vendors. * 
Attends site visits as necessary (e.g., site initiation, monitoring, and close out visits). * 
Contributes to process improvements that help foster continuous improvement. 
Helps update and maintain study trackers and dashboards. 
Participates in system user acceptance testing. 
Manages vendors such as Core Lab.* 
Organizes and manages Investigator Meetings. * 
Works with data management to develop systems for and track project metrics. 
Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *  
Understands relevant security, privacy and compliance principles and adheres to the regulations, standards, and procedures that are applicable to the Company. *  
Ensure other members of the department follow the QMS, regulations, standards, and procedures.*  
Perform other work-related duties as assigned.  
*Indicates an essential function of the role  
 
Position Qualifications 
Minimum education and experience: 
Bachelor’s degree or equivalent experience in a related field, with 2+ years of relevant clinical trial experience (clinical/scientific research, nursing, or medical devices/pharmaceutical industry), or an equivalent combination of education and experience 

Additional qualifications:      
Must be familiar with laws, regulations, standards, and guidance governing the conduct of clinical studies including knowledge of CFR and GCP/ICH requirements 
Proficiency with Microsoft Office, MS Project, EDC Systems, study management systems, and vendor oversight 
Project Management experience 
Excellent oral, written, and interpersonal communication skills, fluency in English & local language, if different, required 
Ability to solve problems creatively with keen attention to details 
Ability to work on teams on multiple projects simultaneously.  
Working knowledge of medical terminology required
High degree of accuracy and attention to detail 
Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously 
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc. 

What We Offer:
• A collaborative teamwork environment where learning is constant and performance is rewarded
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases
• A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan
 
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
 
PENUMBRA, INC.
Affirmative Action and Equal Employment Opportunity Policy Statement
As of October 14, 2022
Penumbra, Inc. has been and will continue to be an equal opportunity employer. Employee diversity has been and will continue to be pivotal to our Company's success. Penumbra recognizes that diversity and inclusion in the workplace enhance employee engagement and stimulate innovation. To assure full implementation of this equal employment policy, we will take steps to assure that:
a)Persons are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

b)All other personnel actions, such as compensation, benefits, transfers, layoffs and recall from layoffs, access to training and education are administered without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

c)Employees and applicants shall not be subjected to harassment, intimidation, threats, coercion or discrimination because they have: (1) filed a complaint; (2) assisted or participated in an investigation, compliance review, hearing or any other activity related to the administration of any federal, state or local law requiring equal employment opportunity; (3) opposed any act or practice made unlawful by any federal, state or local law requiring equal opportunity or (4) exercised any other right protected by federal, state or local law requiring equal opportunity.

I have appointed Sharon Hughes to take on the responsibilities of EEO Coordinator. The EEO Coordinator and those designated will be responsible for the day-to-day implementation and monitoring of the Company's Affirmative Action Plan. As part of that responsibility, the EEO Coordinator will periodically analyze the Company's personnel actions and their effects to ensure compliance with our equal employment policy and administer the audit and reporting system.

If you, as one of our employees or as an applicant for employment, have any questions about this policy or would like to view portions of the Affirmative Action Plan, please contact Ines Kramer during regular business hours. This is also a reminder that employees may update their disability status at any time by completing the voluntary self- identification of disability form on UKG Pro (found in the Private Info tab).

I have reviewed and fully endorse our Affirmative Action and Equal Employment Opportunity program. Thank you for your continued assistance and support of our shared objective of equal employment opportunity for all.

Adam Elsesser
Chief Executive Officer

If you reside in the State of California, please also refer to Penumbra’s Privacy Notice for California Residents.