Send Analyst

For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

**Job Summary**:
We are seeking an **SEND Analyst**, for our SEND Services (remote position).

The following are responsibilities related to the **SEND Analyst**:

- _Create specific SEND domains and/or Define file in adherence with CDISC standards and/or ship SEND deliverables in adherence with requirements._
- _Understand industry documents such as the study plan/protocol, study schedules, deviations, drafts and final reports._
- _Understand CDISC controlled terminology, if applicable._
- _Ensure work is compliant with applicable guidelines and regulations (e.g., CDISC)_
- _Use independent judgement to provide solutions to inconsistencies between SEND data sets and study documentation or to escalate to management in a timely manner._
- _Provide nSDRG content on specific SEND domains, if applicable_
- _Consistently deliver high-quality services and deliver on time._
- _Communicate effectively._
- _Provides regular project status/updates to management._
- _Informs management of any issues that may potentially impact quality and/or on time delivery of SEND data._
- _Maintaining an in-depth understanding of evolving CDISC SEND standards and other regulatory standards/guidance._
- _Perform all other related duties as assigned._

**Job Qualifications**:
The following are minimum qualifications related to the SEND Analyst position:

- Education : Bachelor’s degree (B.A. /B.S.) or equivalent experience in a scientific or related discipline.
- Experience: Two to three years related experience in a scientific environment.

An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

This position requires analytical thinking skills and a good understanding of scientific data. Basic familiarity with Microsoft Office suite and proficiency with MS Excel required. Ability to learn new software systems required. Requires excellent communication and interpersonal skills. Ability to work independently. Requires great attention to detail. Ability to work well in a team environment. Knowledge of the Provantis system and/or knowledge of data reporting and quality control would be valuable assets. Ability to adhere to timelines. Flexibility in work schedule to accommodate deadlines. Ability to work extended hours beyond normal work schedule as needed. Ability to travel as needed; limited travel is expected.
- The advantages of working for Charles River:
- Minimum of 3 weeks’ vacation
- Paid sick / personal days
- Competitive benefits starting from day one (health and dental coverage)
- Access to a savings and retirement program including an employer contribution
- Free, unlimited, and confidential access to health care professionals for you and your family, through telemedicine app
- Employee Assistance Programs
- Tuition reimbursement program
- Employee Activities
- Volunteering Program (paid day)
- Employee referral bonuses
- Relocation assistance
- Career advancement opportunities and training
- A recognition program
- Positive Company Values & Culture

**About Safety Assessment**
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.