Address
Form of work
SalaryThis scientific position is responsible for directing and managing the development of materials as well as the monitoring of activities and data within active imaging trials.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Read, comprehend and summarize various study documents (Clinical Investigation Protocol, client contracts, etc.) to understand and communicate the role of imaging in the specific trial.
- Develop various imaging protocol documents in the support of a clinical trial protocol, study contract or related in capable of supporting a client’s regulatory submission.
- Investigate current industry literature, technology, methodology and accepted practices for imaging techniques to support authoritative recommendations for the use of imaging in client projects.
- Collaborate with internal and/or external subject matter experts to establish best practices and endorsements for imaging techniques used in clinical trials.
- Serve as subject matter expert for the use of imaging technology in support of clinical trials in order to provide internal and external support, to educate clients or potential clients, and to establish awareness and drive collaboration and project efficiencies across service lines.
- Independently lead and guide a client or client designee (e.g. site) during all stages within an imaging study to include:
- Gathering project requirements and serving as an internal client advocate.
- Developing study documentation and processes in support of the trial protocol and executed statement of work, contract or documented change order/addendum/amendment.
- Provisioning, distributing, tracking equipment and supplies.
- Creating, running, distributing reports.
- Archiving study data and documentation.
- Conducting status update and other meetings and appropriately setting and fulfilling of client expectations.
- Conducting training on our provided solutions and protocols to clients, sites, investigators and others, to include the Investigator’s Meetings if required.
- Monitor imaging timelines and manage the financial components of each trial, which includes: Budget reviews; Revenue forecasting; Scope changes; Invoice reconciliation.
- Identify potential opportunities and risks, including mitigations, within a study and inform and escalate as appropriate.
- Manage internal/external dialogues and promote collaboration to foster a positive team environment, effective communications, and efficient use of resources to meet study timelines and contractual obligations.
- Develop and apply problem solving strategies to address client issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to escalations.
- Contribute in the readiness activities of new product initiatives (NPIs).
OTHER DUTIES AND RESPONSIBILITIES:
- Influence strategic decision making and implement team objectives according to schedule.
- Facilitate internal collaborations and communications by serving as a liaison between imaging and other product/service lines or departments.
- Conduct QA/QC or de-identification of images, review systems and documents to ensure high quality of deliverables to the client.
- Provide accurate and detailed project time reports, complete assignments within the prescribed timeline, seeking supervision/consultation/assistance in a timely manner.
- Consistently and dependably engage in the process of critical thinking in order to formulate and implement recommendations or decisions.
- Ensure compliance for self and team, with timely training completion/documentation.
- Provide imaging support to internal team members from other areas of the organization to include attending client meetings with Business Development to present imaging services and workflow as needed and participate in sales initiatives to generate incremental revenue.
QUALIFICATIONS AND SKILLS NEEDED:
Education:
- Ph.D. in biomedical engineering or equivalent. Experience desired in areas where degree is not held and additionally, data management and imaging. Extensive experience in lieu of degree will be considered.
Experience:
- Ten or more years of related scientific project leadership experience with additional experience preferred in the workflows within one or more of: clinical trial management, healthcare management or operations, pre-clinical research, biomedical sciences or R&D.
- Must be computer literate with advanced application knowledge of Microsoft Word, Excel, PowerPoint, database querying, e-mail and electronic calendar.
- Must have a valid passport and the ability to travel.
- Detail oriented and demonstrated responsiveness to inquiries and requests.
- Knowledge of risk management techniques and the ability to analyze and resolve problems.
- Experience working in a regulated industry, preferably within pharmaceutical, medical device or medical imaging.
- Excellent communication and organizational skills with a strong ability to collaborate in English with teams of research scientists, bioinformaticians, software developers, and external collaborators. Will have frequent interaction with clients, suppliers, management and staff including the requirement to present study workflows and/or processes.
- Ability to establish priorities, work independently, and proceed with objectives with minimal supervision in order to deliver high quality at high productivity.
- Ability to mentor and lead others in development and administrative tasks.
EEO Statement
Clario is an equal opportunity employer. Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.
The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. Clario reserves the right to amend or change this job description to meet the needs of Clario. This job description and any attachments do not constitute or represent a contract.
The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications.
