Senior Clinical Data Manager

Supernus Pharmaceuticals, Inc.; Rockville (MD); On-site; USD 145,000 - 160,000; Full time

Benefits offered by this job

Health insurance

401k company match

Paid time off

Discretionary annual bonus program

Job summary

A leading biopharmaceutical company in Rockville, MD, seeks a Clinical Data Management Lead to oversee all data management activities for multiple clinical trials. The ideal candidate will have a Master’s degree and significant experience in the pharmaceutical industry, particularly in clinical data management. Your role will involve collaboration with cross-functional teams and ensuring compliance with industry standards. The position offers a competitive salary range of $145,000 to $160,000, along with comprehensive benefits.

Qualifications

• Master’s or Bachelor’s degree with requisite experience in the industry.
• Strong background in data capture systems and clinical data review.
• Familiarity with industry standards like GCP, GCDMP, and CDISC.

Responsibilities

• Lead data management activities for clinical trials.
• Develop study protocols and contribute to reports.
• Collaborate with cross-functional teams to ensure compliance.

Skills

Data capture systems

Clinical data review

Project management

Interpersonal skills

Attention to detail

Education

Master’s degree in related field

Bachelor’s degree in related field with 8 years experience

Tools

Microsoft Office

Job description

Maryland, 9715 Key West Ave, Rockville, MD 20850, USA

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. We currently have 8 products in the market that are making a real impact on patient outcomes.

Job Summary

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.

• 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.

Supervisory Responsibilities

• 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.

Knowledge & Other Qualifications

• Master’s degree with at least 6 years or Bachelor’s degree with at least 8 years of experience in pharmaceutical, CRO, Biotech, or health‑related field or industry.
• Strong experience in data capture 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.

Other Characteristics

• 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.

Physical Requirements / Work Environment

• 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.

Compensation

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.

Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.