Clinical Operations Specialist

2 weeks ago

Irvine, United States Planet Pharma Full time

This position is a contract-to-hire role with a leading medical device company in Irvine, CA. Candidates must have hands-on experience with medical device/imaging clinical trials, and be located in the greater Irvine, CA area and able to go onsite to be considered.


Location: Onsite 4 days a week at Irvine, CA office - no exceptions


Schedule: 8 am PST to 5 pm PST, Monday through Friday


Duration: 12 months w/ opportunities on the team to go FTE based on performance


Pay: $35-43 per hour based on experience. Medical, Dental, Vision, 401K, Life Insurance, etc available


Must haves:

  • 3-5 years of Clinical trial/research experience with medical devices. If in a cardiovascular or clinical imaging setting, a huge plus
  • Track record of supporting 3 or more ongoing trials at one time.
  • Recent work experience with EDC Medidata Rave.
  • Highly skilled in Excel & SharePoint.
  • Experienced with interpreting clinical data.


Summary:

As the Clinical Operations Analyst for our Transcatheter Heart Valve team, you will be responsible for providing project management of dynamic and high-volume core lab projects across all Transcatheter Heart Valve global clinical studies to ensure accurate and timely transfer of images from study sites to Independent Core Labs, and clinical data from Independent Core Labs to data management teams to ultimately provide unbiased study results.


Key Responsibilities:

• Analyze clinical output of moderately complex studies and provide high level summary with supporting details of study trial status (e.g., Core Lab image perspective) to stakeholders and clinical management

• Identify technical and data issues and collaborate with appropriate team members to bring to resolution; assist in the determination of root cause and recommend and implement corrective actions

• Identify, develop, recommend, and implement moderately complex process development and process improvement solutions to optimize global trial workflow timelines, (e.g., open information requests, aging issues, status of image analysis from Core Labs to study database, etc.)

• Develop basic timeline assessment and/or work with senior level team members on complex timeline assessment (e.g., clinical site through Image workflow vendor to Independent Core Lab) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines

• Provide guidance and represent department to communicate risk and impact to study core team's key milestones and deliverables

• Assist in the development of training material content in collaboration with clinical stakeholders for clinical sites and clinical field staff


Additional Skills:

• Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery

• Experience with an ERP software, JDE and CTMS (Clinical Trial Management System) preferred

• Good written and verbal communication skills and interpersonal relationship skills

• Ability to work in a fast paced environment

• Substantial knowledge and understanding of policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical study documentation

• Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint

• Good problem-solving skills

• Ability to manage confidential information with discretion

• Strict attention to detail

• Ability to interact professionally with all organizational levels

• Must be able to work in a team environment under minimal supervision

• No instructions needed on routine work, and general instructions given only on new lines of work or special assignments

• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control


Required Education and Experience:

•Bachelor's Degree in STEM or healthcare

•3-5 years of hands-on clinical research experience in Medical Devices

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