Memberof the clinical team responsible for engaging in active post-market datagathering activities to generate clinical evidence, provide clinical contextfor products after commercialization. This team member collaborates withinternal and external resources to develop new sources of data and to generate,analyze, and report evidence related to the use of products throughout theirlifecycles.
Design, plan, and track execution of post-marketsurveillance activities including healthcare provider surveys, expert reports,or aggregated data review
Design and plan data extractions from registriesor other secondary uses of data, alongside other clinical and cross-functionalstaff
Collaborate with other functions to inform datacollection and analysis
Liaise with different class of trade leads andclinical operations leaders to assist in the planning of post-market activitiesand report out the data
Generate summary reports of the data analysisactivities
Manage vendors (internal and external) to ensuretimely completion of deliverables
Prepare drafts of the clinical portion ofregulatory submissions for local and government regulatory bodies.
Serve as Clinical Affairs representative onassigned project teams to develop clinical strategies that support corporateand departmental objectives. Provide clinical and technical feedback to cross-functionalteams during project team meetings.
Perform comprehensive literature searches todevelop and maintain in-depth knowledge and understanding of current scientificliterature required to support assigned product lines and related clinicalstudies, staying informed about applicable clinical landscapes and trends.
Reports product complaints as necessary topost-market vigilance function
Provides project updates to effectivelycommunicate to management on a regular basis.
May participate in work streams and/or processimprovement initiatives.
May serve as Super User/Administrator responsibilitiesfor systems (Agile, SharePoint).
Must Have: MinimumQualifications
Bachelors degree required
Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience
Nice to Have
Knowledgeof and experience in study design and basic understanding of statisticalmethods preferred.
Experience with secondary analysisof datasets
Experience with research methodology, including survey research
Experiencecollaborating with or working within data management
Experience in medical field, medical device, orpharmaceutical industry in clinical research/ regulatory affairs/ post-marketvigilance or quality/ risk management function.
Experience managing vendor and/or other partnersto ensure timely completion of deliverables
Experience in technical/scientific principlesand writing
Process-oriented, is willing to take on newtasks and standardize them into a consistent approach while respecting nuancesof different circumstances
Effective analytical and problem-solving skills.
Able to identify and meet the expectations ofinternal and external customers with minimal guidance and interactindependently and in a respectful manner.
Physical Job Requirements
Theabove statements are intended to describe the general nature and level of workbeing performed by employees assigned to this position, but they are not anexhaustive list of all the required responsibilities and skills of thisposition.
Thephysical demands described within the Day in the Life section of this jobdescription are representative of those that must be met by an employee tosuccessfully perform the essential functions of this job. Reasonable accommodations may be made toenable individuals with disabilities to perform the essential functions.