Clinical Study Manager

2 weeks ago

Montreal, Quebec, Canada Altasciences Full time
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.


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 oversee all study related procedures.
  • Act as a resource to indirect reports as well Clinical Operations team members.
  • Oversee trial progression and communications regarding the trial's progression to clients, internal departments, etc.
  • Participate in protocol and ICF reviews.
  • Coordinate operations to meet protocol requirements and predefined study timelines.
  • Proactively define any needs required to accomplish timelines.
  • Ensure the creation of study specific SOPs, training or other materials as needed for study specific procedures.
  • Conduct protocol training and/or coordinate any required training(s) on study specific procedures.
  • Ensure Onsite 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 in 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 followup 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.

What you need to succeed:

  • DEC or higherlevel degree in sciences or related field;
  • Minimum 2 years' experience in within a GxP research environment/CRO;
  • Excellent written and verbal communication (French and English),
  • Leadership and organizational skills.
  • Customer service focused, able to work in a fastpaced environment.
  • Flexible work hours when studies are ongoing including some weekends.
What We Offer
Permanent position, full-time;

Full time: 37.5 hours of work over 5 days per week;

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
RRSP with Employer Match
Paid Vacation and Holidays
Paid Sick and Bereavement Leave
Employee Assistance & Telehealth Programs

Altasciences' Incentive Programs Include:

Training & Development Programs
Employee Referral Bonus Program
Annual Performance Reviews

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

  • Fsp - Clinical Project Manager

    2 weeks ago

    Montreal, Quebec, Canada Allphase Clinical Research Inc. Full time

    Your responsibilities include, but are not limited to: - Lead local evidence generation strategy and operations for key products/indications; Endtoend management of local study design, analysis and communication of results for local clientsponsored studies; Management of local research budget forecast, management and reconciliation; Management of operations...

  • Early Phase Project Manager Ii

    2 weeks ago

    Montreal, Quebec, Canada Syneos Health Clinical Full time

    DescriptionProject Manager IISyneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve...

  • Clinical Project Manager

    2 weeks ago

    Montreal, Quebec, Canada Novartis Full time

    394129BRClinical Project Manager - Site & Study Operations(SSO):CanadaAbout the roleLocation: Montreal, #LI-HybridAbout the role:We are looking for an innovative, experienced, and agile project manager who wants to have an impact on day-to-day planning, executing, and reporting of Global Drug Development (GDD) studies and make a difference in joining us to...

  • Clinical Research Manager

    2 weeks ago

    Montreal, Quebec, Canada Parexel Full time

    PXL is seeking a Clinical Research Manager (CRM) in Canada for one of our large FSP clients This is a remote position with some travel.Oncology experience is preferred Position Purpose:The Clinical Research Manager (CRM) is responsible for the following:Primarily accountable for end-to-end performance and project management for assigned protocols in a...

  • Sso Clinical Project Manager

    2 weeks ago

    Montreal, Quebec, Canada Novartis Full time

    100,000. That's how many patients participate in our clinical trials at any given time. Global Clinical Operations (GCO) touches patients' lives every day acting as a link between science and medicine. Envision the impact you could have #GCOThe SSO Clinical Project Manager (CPM) is accountable for the day-to-day planning, executing and reporting, (from first...

  • FSP - Clinical Project Manager

    2 weeks ago

    Montreal, Quebec, Canada Collage HR Full time

    Functional Service Provider (FSP) Full Time Montreal, QC Job Title: FSP - Clinical Project Manager Date: May 17, 2024 Location: Montreal, QC Remote: Yes Business Unit: Health Division: Pharma - CRO Calian Contract Research Organization (Calian CRO) is looking for a Clinical Project Manager (CPM) on behalf of our client. This a remote FSP position,...

  • Clinical Operations Manager

    2 weeks ago

    Montreal, Quebec, Canada ICON Full time

    As a Clinical Operations Manager - Regulatory, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.What you will be doing:The Clinical Operations Manager is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to...

  • Manager, Clinical Support

    2 weeks ago

    Montreal, Quebec, Canada Innovaderm Research Full time

    Manager, Clinical Support, Head office, Montreal, QcThe Manager, Clinical Support works in close collaboration with the Director, Clinical Research Unit and Clinical staff to manage team and offer support at the various stages of the management of Clinical Research.The manager is responsible to lead the activities and for overseeing the day-to-day management...

  • Clinical Trial Administrator

    2 weeks ago

    Montreal, Quebec, Canada Fortrea Full time

    Clinical Trial AdministratorMontreal, QCHybrid 50% client office / 50% home-basedBilingual in English and French requiredAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of...

  • Clinical Trial Administrator

    2 weeks ago

    Montreal, Quebec, Canada Labcorp Full time

    Clinical Trial AdministratorMontreal, QCHybrid 50% client office / 50% home-basedWhy settle for one thing when you can have everything? Labcorp Drug Development gives you the best two for one opportunity for career growth. Who doesn't want twice the perks - working at one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic...

  • French-speak Clinical Associate

    2 weeks ago

    Montreal, Quebec, Canada Icon plc Full time

    At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration,...

  • Clinical Research Coordinator

    2 weeks ago

    Montreal, Quebec, Canada Centre universitaire de santé McGill Full time

    Organization descriptionLe Centre universitaire de santé McGill (CUSM) est un centre hospitalier universitaire intégré, reconnu à l'échelle internationale pour l'excellence de ses programmes cliniques, de sa recherche et de son enseignement. Le CUSM a pour objectif d'assurer aux patients des soins fondés sur les connaissances les plus avancées dans le...

  • Clinical Research Clerk

    2 weeks ago

    Montreal, Quebec, Canada Research Institute of the McGill University Health Centre Full time

    Do you want to work for a world-renowned research institute that pushes the boundaries of biomedical science and health research? Right here in Montreal At the Research Institute of the McGill University Health Centre (RI-MUHC), you can be part of an organization focused on scientific discovery and innovation in patient-centered medicine. Join us today and...

  • Clinical Research Technician

    2 weeks ago

    Montreal, Quebec, Canada Altasciences Co. Full time

    Your New CompanyAt 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...

  • Head of Non-Clinical

    2 weeks ago

    Montreal, Quebec, Canada Unique Human Capital AS Full time

    A key role in a biotech company focused on developing innovative treatment approaches in immunology and inflammation.As the Head of Non-Clinical at MC2 Therapeutics, you will step into a dynamic and newly established position reporting directly to the COO.This role will give you the opportunity to make a significant impact as the primary non-clinical expert...

  • Clinical Trial Coordinator

    2 weeks ago

    Montreal, Quebec, Canada Fortrea Full time

    Clinical Trial Coordinator - Regulatory Hybrid Montreal QCFortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we...

  • Clinical Research Coordinator

    2 weeks ago

    Montreal, Quebec, Canada Research Institute of the McGill University Health Centre Full time

    Do you want to work for a world-renowned research institute that pushes the boundaries of biomedical science and health research? Right here in Montreal At the Research Institute of the McGill University Health Centre (RI-MUHC), you can be part of an organization focused on scientific discovery and innovation in patient-centered medicine. Join us today and...

  • Clinical Operations Manager

    2 weeks ago

    Montreal, Quebec, Canada Innovaderm Research Full time

    Clinical Operations Manager / Sr. CRA or Sr CTM - Hybrid role - Maternity leave temporary replacement (hybrid role 70% COM & 30% Sr CRA) OR (hybrid role 70% COM & 30 % Sr CTM)The Clinical Operations Manager (COM) is responsible for the day-to-day management of an assigned team of both permanent and contracted staff (e.g., Clinical Research Associates...

  • Clinical Trials Administrator I

    2 weeks ago

    Montreal, Quebec, Canada Labcorp Full time

    Clinical Trial Administrator - FSPHybrid Office/Home-Based - Montreal, QuebecMust be bilingual (English/French)As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the...

  • Clinical Trial Coordinator

    2 weeks ago

    Montreal, Quebec, Canada ICON plc Full time

    ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.What you will be doing:Clinical Trial Coordinator (CTC)Trial and site administration: Track (e.g....