Job Details

ID #20228572
State California
City San diego
Job type Contract
Salary USD Depends on Experience Depends on Experience
Source NetSource, Inc.
Showed 2021-09-25
Date 2021-09-24
Deadline 2021-11-22
Category Et cetera
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Medical/Monitor MD

California, San diego, 92101 San diego USA

Vacancy expired!

Please note this is a 1 year contract position.POSITION SUMMARY:The Medical Monitor in Experimental Medicine Neuroscience is a responsible member of the clinicalteam providing medical expertise and medical oversight for the entire clinical trial, from initial studydesign through final study close-out. The medical monitor provides active medical contribution to across-functional clinical team for each study assigned in early development. The medical monitor isresponsible for the medical monitoring, safety activities, assessment and understanding of druginduced 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 trialESSENTIAL FUNCTIONS:Responsible for all medical and safety aspects for the assigned neuroscience earlydevelopment study(s)Responsible for medical monitoring/reporting and evaluation of adverse events in earlydevelopment clinical trials.Act as the liaison between the clinical team and investigational site for all safety relatedaspects.Provide safety/medical interpretation and reporting of clinical research results.Takes responsibility for the safety/medical aspects of the trial protocol and clinical studyreports.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 theRisk benefit document, possible amendments and other submission or regulatorydocuments within the specified timelines.Review (e)CRF and other data collection tools to ensure that all necessary data arecollected as requested per Clinical Trial Protocol.Contributes to the creation of a major protocol deviation listDevelops an appropriate Medical Review Plan that allows study related safety follow-up in atimely manner.Provides input in site selection when applicable.Supports the clinical team for Investigator Meetings, Site Initiation Visits and Trial andCompound trainings.Reviews and assess in a timely manner in- and exclusion criteria, adverse event of othersafety questions.Provides the Clinical Leader, the Molecule Responsible Physician and the Medical SafetyOfficer 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 groupmeetings or other relevant trial meetings.Liaises with investigational sites, clinicians as necessaryReviews and corrects where needed in a timely manner the Medical Coding andconcomitant medication lists.Contributes to and review Topline Results, Clinical Study Report, Plain LanguageSummary, Clinical Trial RegistryContributes to the development and improvement of departmental procedures andprocesses and templates in the scope of the company’s effort towards continuous qualityimprovementThis 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 franchiseContacts Outside the Company:Be the liaison between the clinical team and investigational sites for any safety relatedaspectsThe Medical monitor acts as a liaison between the clinical study team and clinicalinvestigators for all medical/safety related aspectsThe Medical monitor develops credible relationships with scientific leaders, medical leaders,EtcEducation:MD in relevant area with appropriate training and certificationQualificationExperience in medical monitoring of clinical trials, trial execution and regulatory filing isrequired.At least 3 years of industry experience (or equivalent) in clinical research that has exposedthe individual to the rigors of human trial conduct with pharmaceuticals or medical devices.Experience and knowledge of Good Clinical Practices and regulatory requirements for theconduct 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 amatrix management organization is desirable.Working knowledge of the use of Microsoft suite of software products including Power Pointand 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.Applicants must provide their phone number. Job reference number A1089.

Vacancy expired!

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