Job Description

Job Description

Job Description

Salary:

Who Are We?

Founded in 1997 and built upon 27+ years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diegos Top Workplaces, we take pride in maintaining a company culture that values collaboration, diversity of background and thought, and dedicated talent. When you join Therapeutics, you are not a number or a cog in the wheel, you are valued for your unique and important contributions that you bring to our team and our clients.

Who Are You?

You are a dedicated individual who is passionate about your work and you want to join a team that believes a company is only as successful as its people. You lead with humility and know that your individual contribution is important so you take pride in delivering great work. You believe anything worth doing, is worth doing right. You communicate clearly and have great attention to detail. You love to collaborate with the team but are able to think on your feet to problem-solve independently.

What is the Primary Objective of the Sr. Clinical Data Manager (CDM)?

This position is responsible for data management activities, including developing data management plans, validating/testing databases, defining specifications to review data (manual, automatic (EDC edit checks), and SAS validations), and reviewing/tracking clinical trial data to ensure the completeness, accuracy, and consistency of the data collected during clinical trials.

Study Specific Activities

• Coordinate and complete data management activities to meet project timelines and communicate status to clinical project managers.
• Develop study specific data management plans and case report form (CRF) completion guidelines.
• Review and approve documents associated with data collection: CRFs, edit checks, data handling conventions, and data entry instructions.
• Review and finalize clinical study database validation plans, lead the database validation team, and ensure all documentation is completed prior to GO-LIVE.
• Complete data verification process (i.e., issue data clarification forms (DCFs) for paper CRFs or issue queries for EDC). Review completed DCFs and/or queries to ensure data discrepancies are resolved in the database.
• Prepare electronic data transfer protocols and coordinate data transfers (imports and exports) with third party vendors and consultants and Project Biostatisticians.
• Lead database cleaning and lock activities, coordinating data transfer reconciliation, serious adverse event reconciliation, and database audits with QA or data quality reviews with another Clinical Data Manager.
• Ensure all study specific documentation is filed appropriately in the study-specific Trial Master File.

General Activities

• Manage and prioritize data management activities to meet project schedules.
• Report on required data management metrics to ensure efficient review of data.
• Develop data management resource forecasting and tracking model to assist with project planning and support.
• Optimize database development and validation processes to improve departmental efficiency
• Train and mentor Clinical Data Associate(s) to develop clinical data review and other technical data management skills.

To Succeed in this Position:

• Ideally, you will have a Bachelors degree in a scientific discipline, at least 5 years of clinical data management experience in the pharmaceutical/biotechnology industry. More experience will be required for a senior level CDM candidate.
• You must be highly detail-oriented while still maintaining work efficiency, be able to prioritize activities and multi-task across various projects that will be at different study stages. We prefer you to have MedDRA and WHO Drug coding proficiency.
• You should have previous experience with reviewing data and database validation for EDC (Viedoc EDC is preferred) is required.
• Knowledge of CDISC/SDTM standards is also highly desired.
• If you are a remote-based candidate, you must reside and work in the PST, MST, or CST time zone. If you are a local candidate based in San Diego County, you will be required to work onsite at our San Diego office following a hybrid schedule.

The most likely starting base pay range for this position is $120,000 - $130,000 per year depending on title, experience-level of the candidate, location and particular business needs. Consideration will be given to experience that exceeds the listed requirements.

We at Therapeutics, Inc. are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and team members without regard to race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. If you are smart and good at what you do, we welcome you to apply!

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