Operations Manager or eCOA , ePRO Manager
- Employer
- Worldwide Clinical Trials
- Location
- United States
- Salary
- Competitive salary plus benefits package
- Start date
- 13 Mar 2019
- Closing date
- 12 Apr 2019
View more
- Discipline
- Clinical Research, Clinical Operations, Clinical Program Manager, Clinical Project Manager, Clinical Research Associate, Clinical Study Manager, Operations, Operations Management, Project Management, Regulatory Project Management
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Management
Job Details
Join us at worldwide as an Operations Manager and be part of our unique CRO!
The Operations Manager has primary responsibility for overseeing the operational work related to rater selection, rater certification, qualification, rater training content, scale acquisition, surveillance maintenance, and workbook or source document for Worldwide Clinical Trials, Inc. The Operations Manager is responsible for ensuring all assigned projects are conducted in a timely fashion and in a manner compliant with SOPs and ICH, GCP and regulatory guidelines. The Operations Manager works under the direction of the Operations Director, Clinical Assessment Technologies (CAT).
RESPONSIBILITIES:
- Coordinate completeness of rater experience qualification documents and communicating collection results to the Sponsor and study team
- Develop study specific rater training web portals and ensure readiness based on study timelines
- Coordinate logistical matters of the Investigators’ Meetings and associated CAT materials; manager may attend such meetings
- Organize the timely completion of editing and formatting of didactic training presentations
- Oversee scale and study source workbook management by obtaining scale licenses, translations, regulatory authorizations, and Sponsor approvals
- Oversee data surveillance methodology maintenance by tracking and reconciling incoming source documentation and provide reports to the study team and Sponsor
- Provide necessary CAT data to ensure comprehensiveness of CAT’s Final Study Report
- Oversee archiving of all CAT study documents
- Consulted on rater training and data surveillance plans to ensure documents represent Sponsor and protocol specifications
Other Clinical Assessment Responsibilities - May develop and present at sponsor Kick-Off-Meetings regarding CAT operations work
- Work with Operations Director and WCT study team to ensure study budgetary demands are met
- Management of Operations staff, as assigned
OTHER SKILLS AND ABILITIES:
- Highly organized, detail- and service-oriented
- Excellent planning, managing, monitoring, scheduling, and critiquing skills
- Excellent at meeting timelines consistently and being able to effectively work under pressure
- Continuously open to constructive, developmental feedback
- Strong writing and verbal communication skills in order to clearly and concisely present information
- Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
- Strong ability to handle multiple tasks and many administrative details in a fast-paced and constantly changing environment
- Strong self-motivation skills
- Strong ability to work in teams
- Excellent proficiency in all MS-Office applications including Microsoft Word, Excel, Adobe, and PowerPoint
REQUIREMENTS:
- Preferred minimum of Bachelor’s (life sciences) degree preferred
- Previous years clinical trial experience
- Preferred experience of experience managing team members
- Demonstrable knowledge of operational aspects regarding Phase I-IV clinical research trials
- Ample knowledge of SOPs and ICH, GCP and regulatory guidelines
- Competency working with data and numbers
- Fluency in English (will be required to write, speak, and understand English to conduct day-to-day business)
- The role requires travel domestically and internationally in order to attend key meetings. The global nature of the position may also require the incumbent to occasionally manage their time flexibly in order to be responsive to stakeholders in different time zones.
- Experience of eCOA or EPRO
Company
Find out more about working for our company
Brief Company Description;
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
- Website
- https://www.worldwide.com/
- Mini-site
- Worldwide Clinical Trials
- Telephone
- +44 115 956 7711
- Location
-
1st Floor Waterfront House
Beeston Business Park
Beeston
Nottingham
Nottinghamshire
NG9 1LA
United Kingdom
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