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Medical Monitor

Advanced Technology Solutions, Inc.

This is a Contract position in Newark, DE posted September 26, 2021.

The Medical Monitor in Experimental Medicine Neuroscience is a responsible member of the clinical team providing medical expertise and medical oversight for the entire clinical trial, from initial study design through final study close-out.

The medical monitor provides active medical contribution to a cross-functional clinical team for each study assigned in early development.

The medical monitor is responsible for the medical monitoring, safety activities, assessment and understanding of drug induced safety findings in light of patient safety for each assigned trial.

Trained and certified as MD, preferably 3 years of experience in medical monitoring of clinical trial ESSENTIAL FUNCTIONS: Responsible for all medical and safety aspects for the assigned neuroscience early development study(s) Responsible for medical monitoring/reporting and evaluation of adverse events in early development clinical trials.

Act as the liaison between the clinical team and investigational site for all safety related aspects.

Provide safety/medical interpretation and reporting of clinical research results.

Takes responsibility for the safety/medical aspects of the trial protocol and clinical study reports.

Close interactions with Clinical Leaders and Clinical Scientists across studies.

OTHER RESPONSIBILITIES / DETAILED DUTIES: Contribute to the development of the Clinical Trial Protocol, the Informed Consent and the Risk benefit document, possible amendments and other submission or regulatory documents within the specified timelines.

Review (e)CRF and other data collection tools to ensure that all necessary data are collected as requested per Clinical Trial Protocol.

Contributes to the creation of a major protocol deviation list Develops an appropriate Medical Review Plan that allows study related safety follow-up in a timely manner.

Provides input in site selection when applicable.

Supports the clinical team for Investigator Meetings, Site Initiation Visits and Trial and Compound trainings.

Reviews and assess in a timely manner in
– and exclusion criteria, adverse event of other safety questions.

Provides the Clinical Leader, the Molecule Responsible Physician and the Medical Safety Officer with regular updates on daily safety follow-ups of the assigned clinical trial ( includingSerious Adverse Event reporting) Contributes to dose escalation meetings, cross functional team meeting working group meetings or other relevant trial meetings.

Liaises with investigational sites, clinicians as necessary Reviews and corrects where needed in a timely manner the Medical Coding and concomitant medication lists.

Contributes to and review Topline Results, Clinical Study Report, Plain Language Summary, Clinical Trial Registry Contributes to the development and improvement of departmental procedures and processes and templates in the scope of the company’s effort towards continuous quality improvement This is not an exhaustive, but comprehensive listing of job functions.

May perform other duties as assigned.

PRINCIPAL RELATIONSHIPS: Contacts Inside the Company: Member of the Clinical Teams, Safety Management Team, Global Development Organization, Global Safety Organization, therapeutic area and franchise Contacts Outside the Company: Be the liaison between the clinical team and investigational sites for any safety related aspects The Medical monitor acts as a liaison between the clinical study team and clinical investigators for all medical/safety related aspects The Medical monitor develops credible relationships with scientific leaders, medical leaders, Etc Education: MD in relevant area with appropriate training and certification Job Requirements: Qualification Experience in medical monitoring of clinical trials, trial execution and regulatory filing is required.

At least 3 years of industry experience (or equivalent) in clinical research that has exposed the individual to the rigors of human trial conduct with pharmaceuticals or medical devices.

Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings is required.

Previous experience working on Clinical Trial and/or Compound Development Teams in a matrix management organization is desirable.

Working knowledge of the use of Microsoft suite of software products including PowerPoint and Word is required.

The successful candidate must be fluent in written and spoken English.

Willingness and ability to partially adjust work hours to facilitate trans-Atlantic collaboration.

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