Clinical Data Manager

SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experience team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances, positive work/life balance and 401k matching (US), we are able to attract some of the most talented people in the industry.

WHY SDC:

• We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.

• We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.
• We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.
• We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling out growth in this ever- evolving industry.
• With a proven track record, SDC has been successfully executive client clinical programs since 2005.

Take a look at how you can join our team!

The Clinical Data Manager participates in all data management activities in support of clinical and/or non-clinical research studies for study initiation, setup, maintenance, and closeout either as a study lead or backup data manager. Manages the day- today data management project activities including, but not limited to, timelines, budgets, staff, project scope, reports and communication for the lifecycle of the project(s). Mentors/trains Clinical Data Analysts.

***Candidates must reside in Arizona or along the east costal line in US***

Recruiting agencies, please do not submit unsolicited referrals for this or any open role. We have established agency partnerships, and we will not pay any fee associated with unsolicited referrals.

#LI-Remote

Primary Responsibilities

• Perform study setup activities including CRF design, database structure design, annotation, document creation and/or approval, data entry screen design and testing, validation check testing and approval, etc.
• Allocate and prioritize workloads for multiple projects (media control, data entry, pre entry review and query management tasks)
• Serve as a primary or backup resource for issues pertaining to data management
• Serve as an interim resource for issues pertaining to the study in the absence of the Project Clinical Data Manager
• Assist other Clinical Data Managers or Project Managers with management of timelines and budgets as they pertaining to data management activities
• Mentor all levels of Clinical Data Analysts in their job responsibilities
• Maintain quality control of the data, project deliverables and closeouts
• Support and facilitate the review of medical coding for validity and completeness

Requirements

• Preferably located in Arizona, Massachusetts, or North Carolina.
• Competent working knowledge of clinical trials and the clinical data management role in the clinical trials process
• Excellent organizational and project management skills
• Able to lead teams to complete projects
• Highly effective communication skills, both written and verbal
• Technical skills including EDC systems, clinical data management systems, Microsoft Office
• Additional required skills include the following: CRF design, MS Project, and analytical capabilities.
• Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)

Benefits

What you can expect from us:

• We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, and offer a flexible work schedule, engaging work culture, and employee benefits.
• We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.
• We strive to provide a place of belonging to our employees with a fun and engaging activities from SDC’s culture club.
• We are constantly growing and innovating to support our clients and employees' needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.
• With a proven track record, SDC has been successfully executing client clinical programs since 2005.
• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)
• Family Leave (Maternity, Paternity)
• Short-Term & Long-Term Disability
• Training & Development
• Work From Home
• Profit based incentive