Senior Clinical Data Manager

Essential Duties & 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.

Non-Essential Duties & Responsibilities

• Attends and participates in internal and external training sessions.
• Supervises 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 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.

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

• 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.