CTMS Implementation Manager

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. 

Job Title: CTMS Implementation Manager 

Location: Ontario, Canada (Hybrid)     

Function: Service Delivery 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Lead client design consultations by:

• Analyzing client requirements against system capabilities to determine implementation recommendations and best practices.
• Leveraging deep knowledge of internal applications to guide clients toward optimal implementation designs, balancing configuration complexity with site and end-user experience.
• Providing technical expertise during the requirements process and driving specifications discussions forward with internal and external stakeholders.
• Facilitating discussions between internal and external teams to ensure key stakeholders and SMEs are represented and the design reflects expert input.
• Serving as the primary CTMS subject matter expert during client engagements, applying firsthand clinical operations experience to advise on optimal CTMS configuration, workflow design, and trial management best practices.

Implement and review study configurations / system implementation and updates by:

• Configuring study-, project-, and client-specific implementations for Sitero clinical systems based on study protocols, client application requirements, and specifications.
• Conducting demonstrations of system implementations to clients during the development process.
• Soliciting client feedback during demonstrations and making adaptations to the configuration in real time when possible.
• Performing tasks associated with system configuration such as generation of system specific data requirements, staging of data, and liaising with internal teams.
• Leading CTMS-specific implementations, including configuration of study tracking, country and site management, monitoring visit schedules, enrollment tracking, milestone management, and resource allocation modules.

Develop and manage user requirements by:

• Gathering, analyzing, refining, and finalizing user requirements from multiple sources in an iterative manner, ensuring timely and accurate delivery of the product, study, or system to the client.
• Reviewing specification documents to ensure requirements are present and in the correct format.
• Developing the systems specifications including any client facing requirement documents from the study protocol/client system implementation requirements, integrations with external systems, and other supporting applications such as reports.
• Coordinating the schedules of internal and external stakeholders to ensure timely submission of requirements throughout the specification and design processes.
• Translating product features and functionality to the requirements definition stage to reduce confusion and conflict during the testing and "go live" phases of a study, project, or client system implementation.
• Translating real-world clinical trial workflows—such as site activation, monitoring visit tracking, and study close-out—into CTMS-specific requirements, drawing on direct experience as a former CRA or Clinical Project Manager.

Ensure software applications are effectively supported by:

• Performing triage on internally/externally reported system behaviors, escalating to the Product Team when applicable.
• Independently, or collaboratively with the Product Team, defining and documenting steps to reproduce bugs and associated workarounds. Communicating workarounds to clients in conjunction with the Project Manager.
• Writing and/or executing simple, concise unit tests or client-facing test scripts, when applicable.

Secondary Responsibilities

Maintain quality service and departmental standards by:

• Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”).
• Assisting in establishing and enforcing departmental standards.
• Working closely with QA for clarification and documentation of deviations to SOPs.
• Participating in the modification of company SOPs related to Service Delivery.
• Attending and participating in applicable company sponsored training.
• Participating in and taking the lead as SME for CAPA analysis as needed to ensure high standards are upheld.

Contribute to team effort by:

• Working with internal staff to resolve issues.
• Exploring new opportunities to add value to organization and departmental processes.
• Providing recommendations for product enhancements based on industry best practices, competitive landscape awareness, and direct client implementation experience.
• Helping others to achieve results.
• Coaching new Implementation Managers on department processes and SOPs.
• Mentoring junior team members for their professional development.
• Performing other duties as assigned.

Maintains Technical and Industry Knowledge by

• Attending and participating in applicable company-sponsored training

EDUCATION AND EXPERIENCE REQUIRED:

• Bachelor’s degree in life sciences or related field preferred.
• 5+ years’ experience in clinical trials within a CRO or pharmaceutical research organization required; prior experience as a Clinical Research Associate (CRA) or Clinical Project Manager strongly preferred.
• 2+ years implementation experience in business analysis and/or building configurations and specifications for clinical systems.
• 5+ years’ experience in customer facing role.
• Proven ability to effectively lead a diverse team from requirements definition to product sustainability.
• Demonstrable detailed knowledge of eClinical systems including RTSM, EDC, Site and Patient Payments, eConsent, and CTMS, with particular depth in CTMS platforms (e.g., Medidata Rave CTMS, Oracle Siebel CTMS, Veeva Vault CTMS, Bio-Optronics Clinical Conductor, MasterControl).
• Working knowledge of software delivery lifecycle and methodology
• General knowledge of regulatory guidelines from ICH, FDA, EMEA.
• Investigator payments, financial technology experience a plus.
• Hands-on experience as an end user of one or more industry CTMS platforms in a clinical operations, site management, or monitoring capacity required.
• Strong understanding of the clinical trial lifecycle from site selection through close-out, with the ability to advise clients on CTMS best practices based on direct operational experience.
• Familiarity with CTMS integration points to other eClinical systems such as EDC, RTSM, eTMF, and safety databases.

COMPENSATION & BENEFITS:

Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.

EMPLOYMENT TYPE:

Full Time, Permanent

COMMITMENTS:

• Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed.
• Willing to work in shifts as and when needed.

DISCLAIMER: 

Sitero is an equal opportunity employer and welcomes all job applicants.  All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.