Study Manager

CareAbout; Overland Park (KS); On-site; USD 62,000 - 80,000; Full time

Benefits offered by this job

Health/Dental/Vision Insurance Plans

401(k)/RRSP with Employer Match

Paid Vacation and Holidays

Training & Development Programs

Employee Referral BonusProgram

Annual Performance Review

Job summary

Altasciences in Montreal is seeking a Study Manager to oversee the coordination and management of assigned clinical trials in compliance with protocol, GCP and SOPs.

You’ll supervise study procedures, coordinate staffing, manage audits, and liaise with sponsors and QA to ensure timelines and data integrity. Strong English/French communication and leadership are required.

Qualifications

• High School diploma or GED and related job experience required, college degree preferred.
• Excellent written and verbal communication (French and English at the Montreal location), leadership and organizational skills.
• Customer service focused, able to work in a fast-paced environment.

Responsibilities

• Ensure confidentiality of trial participants and sponsors.
• Supervise and/or oversee all study related procedures.
• Act as a resource to indirect reports and Clinical Operations team members.
• Oversee trial progression and communications to clients and internal departments.
• Participate in protocol and ICF reviews.
• Coordinate operations to meet protocol requirements and study timelines.
• Ensure creation of study SOPs, trainings or materials.
• Conduct protocol trainings and coordinate training on study procedures.
• Ensure on-site files are complete and accurate.
• Approve staffing designs and review staffing schedules.
• Assure Investigational Product is received and dispensed per timelines.
• Participate in SOP revisions.
• Prepare for and participate in audits by sponsors, QA, regulators.
• Coordinate study monitoring and respond to monitor queries.
• Record adverse events and concomitant medications; follow up until resolution.
• Obtain and document study events/data per GCP/SOPs.
• Track enrollment status and document enrollment changes.
• Review subject eligibility.

Skills

Communication skills

Bilingual English/French

Leadership

Organizational skills

Customer service

Education

High School diploma or GED

College degree preferred

Job description

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 Study Manager is responsible for the overall supervision, coordination and management of assigned clinical trials in compliance with study protocol, Good Clinical Practices (GCP) and Standard Operating Procedures (SOPs).

What You’ll Do Here

• Ensure the confidentiality of clinical trial participants and sponsors is respected.
• Supervise and/or oversee all study related procedures.
• Act as a resource to indirect reports as well Clinical Operations team members.
• Oversee trial progression and communications in regard to the trial’s progression to clients, internal departments, etc.
• Participate in protocol and ICF reviews.
• Coordinate operations to meet protocol requirements and pre-defined study timelines. Pro-actively define any needs required to accomplish timelines.
• Ensure the creation of study specific SOPs, trainings or other materials as needed for study specific procedures.
• Conduct protocol trainings and/or coordinate any required training(s) on study specific procedures.
• Ensure On-site file(s) are complete and accurate.
• Approve staffing designs and review staffing schedules to ensure sufficient staffing requirements are met based on protocol needs.
• Assure the study Investigational Product (IP) is received and dispensed in lieu with study timeline requirements.
• Participate in SOP revisions.
• Prepare for, participate in and/or act as a liaison for audits conducted by study sponsors, Quality Assurance (QA) and regulatory agencies.
• Coordinate study monitoring. This may include but is not limited to: communications with the monitor, providing study source, responding to monitor queries and coordinating monitor visits.
• Perform protocol specific activities.
• Record adverse events and concomitant medication use and follow up on open adverse events until resolution.
• Obtain and document study related events and data in compliance with GCP/SOPs.
• Track enrollment status and appropriate document enrollment changes.
• Review of subject eligibility for participation.

What You’ll Need to Succeed

• High School diploma or GED and related job experience required, college degree preferred.
• Excellent written and verbal communication (French and English at the Montreal location), leadership and organizational skills.
• Customer service focused, able to work in a fast-paced environment.

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

Altasciences’ Incentive Programs Include:

• Training & Development Programs
• Employee Referral BonusProgram
• Annual Performance Review

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!