Supernus Pharmaceuticals Inc
Senior Clinical Data Associate
Supernus Pharmaceuticals Inc, Rockville, Maryland, us, 20849
Job Summary:
The Senior Clinical Data Associate will be responsible for timely and accurate data delivery (including collection, transfer and documentation). Under the supervision of a senior staff from the Data Management group, the incumbent will work closely with colleagues from Biostatistics, Statistical Programming, Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs.
Essential Duties & Responsibilities:
Maintains data management timelines and metrics.
Reviews clinical study protocols (including schedule of assessments).
Develops electronic case report forms (eCRF) in collaboration with clinical database developer and study team members from Biostatistics, Statistical Programming, Clinical Development and Clinical Operations.
Reviews electronic data capture (EDC) database (including edit check and query logic).
Coordinates User Acceptance Testing (UAT) of EDC.
Develops and executes data management documentation (e.g., data management plan, eCRF completion guidelines, data quality check [and/or oversight plan], and work instructions).
Leads data review/cleaning/transfer/reconciliation activities.
Reviews statistical analysis plan (SAP) and tables/figures/listings (TFLs).
Identifies trends of potential data issues and shares the solution with study team.
Ensures data quality throughout the data lifecycle, from data collection to database lock.
Coordinates archiving of study databases and related documents.
Performs other duties as assigned.
Supervisory Responsibilities:
N/A
Knowledge & Other Qualifications:
Master’s degree with at least 2+ year OR Bachelor’s degree with at least 4+ years of experience in the pharmaceutical/biotech/CRO industry.
Proficient with EDC technology (e.g., RAVE or InForm).
Working knowledge of database application.
Working knowledge of industry standards such as CDISC (e.g., CDASH and SDTM), ICH GCP and SCDM GDMP.
Therapeutical knowledge of psychiatry and/or neuroscience a plus.
SAS experience a plus.
Strong organizational skills with attention to detail.
Excellent interpersonal/verbal communication and written/presentation skills.
Computer literate with proficiency of Microsoft 365 (Word, Excel, PowerPoint) and Adobe PDF.
Other Characteristics:
Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
Ability of having an innovative and dynamic approach to work.
A self-starter able to work independently but comfortable working in a team environment.
Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others.
Capable of performing other duties as assigned by Management.
Authorized to legally work in the United States without visa sponsorship.
Physical Requirements/Work Environment/Travel Requirements:
Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading.
The worker is not substantially exposed to adverse environmental conditions.
Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.
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The Senior Clinical Data Associate will be responsible for timely and accurate data delivery (including collection, transfer and documentation). Under the supervision of a senior staff from the Data Management group, the incumbent will work closely with colleagues from Biostatistics, Statistical Programming, Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs.
Essential Duties & Responsibilities:
Maintains data management timelines and metrics.
Reviews clinical study protocols (including schedule of assessments).
Develops electronic case report forms (eCRF) in collaboration with clinical database developer and study team members from Biostatistics, Statistical Programming, Clinical Development and Clinical Operations.
Reviews electronic data capture (EDC) database (including edit check and query logic).
Coordinates User Acceptance Testing (UAT) of EDC.
Develops and executes data management documentation (e.g., data management plan, eCRF completion guidelines, data quality check [and/or oversight plan], and work instructions).
Leads data review/cleaning/transfer/reconciliation activities.
Reviews statistical analysis plan (SAP) and tables/figures/listings (TFLs).
Identifies trends of potential data issues and shares the solution with study team.
Ensures data quality throughout the data lifecycle, from data collection to database lock.
Coordinates archiving of study databases and related documents.
Performs other duties as assigned.
Supervisory Responsibilities:
N/A
Knowledge & Other Qualifications:
Master’s degree with at least 2+ year OR Bachelor’s degree with at least 4+ years of experience in the pharmaceutical/biotech/CRO industry.
Proficient with EDC technology (e.g., RAVE or InForm).
Working knowledge of database application.
Working knowledge of industry standards such as CDISC (e.g., CDASH and SDTM), ICH GCP and SCDM GDMP.
Therapeutical knowledge of psychiatry and/or neuroscience a plus.
SAS experience a plus.
Strong organizational skills with attention to detail.
Excellent interpersonal/verbal communication and written/presentation skills.
Computer literate with proficiency of Microsoft 365 (Word, Excel, PowerPoint) and Adobe PDF.
Other Characteristics:
Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
Ability of having an innovative and dynamic approach to work.
A self-starter able to work independently but comfortable working in a team environment.
Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others.
Capable of performing other duties as assigned by Management.
Authorized to legally work in the United States without visa sponsorship.
Physical Requirements/Work Environment/Travel Requirements:
Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading.
The worker is not substantially exposed to adverse environmental conditions.
Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.
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