SEND Data Specialist

Your New Company!
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them.No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences.

We are better together and together We Are Altasciences.

About the Role
The SEND Data Specialist I plays an active role in the company’s SEND program. SEND is an FDA required electronic format for nonclinical study data to accompany submission of study reports. The SEND Data Specialist performs business analysis and administration functions that include: continuous process improvement efforts to maximize the business value of our SEND system, assisting study set-up, scheduling, execution, and reporting; providing Helpdesk support for SEND issues; helping to develop processes that are associated with SEND; validation and testing; training; and maintaining the SEND system through change management procedures.

What You’ll do Here

• Ensure preparation of SEND datasets are submission ready, including the harmonization of study data from multiple data sources, including such as sponsors, Provantis, LIMS, test sites, and/or other testing facilities

• Perform a quality control review on the resulting SEND dataset to ensure the data is equivalent to that presented in the study report

• Resolve system errors, disruptions, and concerns as they relate to protocol management (in conjunction with IT staff, as applicable) and communicates resolutions to the appropriate departments

• Develop and utilizes written standard operating procedures based on information security guidelines, regulatory requirements, and industry best practices

• Maintain technical documentation in support of all these duties

• Respond to internal/external audit findings and contribute to corrective actions as needed

• Assist in providing SEND system training and maintaining a robust system training program

What You’ll Need to Succeed

• BS/MS degree, preferably in a scientific or technical discipline; equivalent combination of education, related experience and/or certified training

• 3+ years experience with SEND in a GLP pre-clinical environment preferred

• Experience in a global role in a global healthcare services company preferred

• Intermediate computer skills including Microsoft Office suite and project management tools

• English proficiency required read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals, and write routine reports and correspondence

• Demonstrates excellent oral and written communications and teamwork skills for interaction with a multidisciplinary project team

• Speak effectively before groups of customers or employees of the organization

• Intermediate maths skills as used in the life sciences industry, algebra, and statistics

• Diagnosing, tracking and solving system problems

• Demonstrates strong support for customers and team members, carefully follows verbal and written instruction and contributes independently or as team member

• Positive customer service orientation, with a quality oriented work ethic

• Development and utilization of written procedures, checklists and test plans required

• Key skills include strong computer and writing skills, attention to detail, excellent interpersonal and organizational skills

Altasciences strives to provide a French work environment for its employees in Quebec. Altasciences has taken all reasonable steps to avoid imposing the above language requirement other than French. This requirement is essential for the position of Employee Experience Consultant for, but not limited to, the following reason(s):

• The employee frequently communicates with Altasciences employees across Canada and the United States. As such, English is the primary language used to correspond between offices.

• The employee frequently communicates with English-only customers outside the province of Quebec.

What We Offer  

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences’ Benefits Package Includes:

• Health/Dental/Vision Insurance Plans

• 401(k)/RRSP with Employer Match

• Paid Vacation and Holidays

• Paid Sick and Bereavement Leave

• Employee Assistance & Telehealth Programs

• Telework when applicable

Altasciences’ Incentive Programs Include:

• Training & Development Programs

• Employee Referral Bonus Program

• Annual Performance Reviews

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MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH

Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!