Senior Clinical Data Manager at Supernus Pharmaceuticals, Inc. in Rockville, MD

Job description

• Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes.
• To provide leadership, strategic direction, and oversight for end-to-end clinical data management activities throughout the lifecycle of clinical trials – from study start-up through trial execution and study closeout – ensuring quality, compliant, and timely clinical data delivery.

Responsibilities

• Lead all data management (DM) activities for one or more clinical trials.
• Contribute to developing study protocols, statistical analysis plans, and clinical study reports.
• Collaborate with Database Development on study database, eCRF, and edit checks design.
• Manage user acceptance testing (UAT) of study database with cross-functional team members (including Clinical Operations, Clinical Development, Drug Safety, and Biostatistics).
• Manage cross-functional collaboration with internal team members (from Clinical Operations, Clinical Development, Drug Safety, and Biostatistics) and external vendors (for trial conduct).
• Develop and enforce study timeline for all DM and/or DM-related milestones.
• Develop and enforce all DM-related plans, agreements, and guidelines (e.g., data management plan [DMP], data quality plan [DQC], data transfer agreement [DTA], and electronic CRF completion guidelines [eCCG]).
• Collaborate with Document Management team to archive DM-related documents in Trial Master File (TMF).
• Write DM-related SOPs and/or Job aids and contribute to improving DM processes.
• Attends and participates in internal and external training sessions.
• May supervise Clinical Data Associates as needed.
• Provides leadership or management in an effective manner consistent with Company Values towards defined Corporate Objectives.
• Understands Company Policy and procedure to be able to guide direct reports appropriately, if applicable.

Requirements

• Master’s degree with at least 6 years or Bachelor’s degree with at least 8 years of in pharmaceutical, CRO, Biotech, or health related field or industry.
• Strong experience in data captures systems and clinical data review.
• Strong knowledge of industry standards such as GCP, GCDMP, and CDISC (CDASH and SDTM).
• Working knowledge of medical terminology and coding (MedDRA/WHO-Drug).
• Working knowledge of data privacy rules in relation to clinical data management.
• Nursing/medical/biology background is a plus.
• Strong project and risk management skills with great attention to detail.
• Excellent interpersonal and communication skills in English language (writing, speaking, and comprehending).
• Computer literate with proficiency of Microsoft Office package including Word, Outlook, and Excel.
• Ability to work independently and as part of a team.
• Ability to maintain high ethical standards of integrity and quality.
• Capable of performing other duties as assigned by management.
• Capable of being innovative and dynamic in approach to work.
• Authorized to legally work in the United States without visa sponsorship.

Skills

Required

• Data capture systems
• Clinical data review
• GCP
• GCDMP
• CDISC (CDASH and SDTM)
• MedDRA/WHO-Drug
• Microsoft Office (Word, Outlook, Excel)

Benefits

• At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $145,000 to $160,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual’s salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs.
• You also will be able to participate in a competitive benefits package, including but not limited to: health, dental, vision, paid time off, 401k company match, company paid life insurance and health and wellness benefits. The total compensation package for this position also includes other compensation elements such as stock equity awards, employee stock purchase programs and participation in our Company’s discretionary annual bonus program.