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Canada
Remote only
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Clinical Data Manager, FSP, Oncology based in Canada.
The Senior Clinical Data Manager will provide strategic and operational leadership across clinical data management activities for oncology studies. In this remote position, you will oversee clinical data management deliverables from study start-up through database lock, ensuring quality, compliance, and timely execution. You will serve as a subject matter expert and primary data management contact for sponsors, translating their requirements into effective study processes. Working closely with cross-functional biometrics and clinical teams, you will coordinate resources, manage project risks, and maintain delivery against agreed timelines and budgets. You will also mentor and develop team members while driving continuous improvement and the adoption of new technologies. This role offers the opportunity to contribute to complex clinical research programs and support the development of life-saving therapies.
You will lead clinical data management activities across assigned oncology studies, ensuring that project deliverables meet sponsor expectations, regulatory requirements, quality standards, and contractual commitments. Key responsibilities include:
Lead clinical data management activities for complex studies involving healthy volunteers and patient populations, multiple sites, complex protocols, or accelerated timelines.
Take accountability for all assigned study deliverables, from study start-up through database lock, ensuring work is completed accurately and according to established timelines.
Guide data management study teams, assign responsibilities, review deliverables, and adjust resource allocation to maintain quality and productivity.
Ensure studies comply with clinical protocols, global harmonized Standard Operating Procedures (SOPs), and Good Clinical Practice (GCP) requirements.
Collaborate with Project Managers, FSP Leads, and cross-functional teams to establish and maintain project timelines and meet contractual milestones.
Lead data-focused project meetings and coordinate deliverables with EDC Design, SAS Programming, Statistics, Pharmacokinetics (PK), and other Biometrics functions.
Identify project risks, develop mitigation strategies, monitor progress toward database lock, and communicate relevant updates to project leadership and sponsors.
Maintain oversight of project budgets, scope changes, resource requirements, and timeline impacts, ensuring sponsor approval for changes where required.
Coordinate the receipt, inventory, and reconciliation of clinical data from sites, laboratories, vendors, and other third-party sources.
Ensure appropriate clinical database reconciliation against safety, laboratory, and other relevant external data.
Build and maintain strong sponsor relationships, monitor client satisfaction, and implement improvement plans when necessary.
Provide technical leadership, mentoring, coaching, and training to data management team members, supporting their professional development and adherence to competency standards.
Contribute to performance evaluations by providing constructive feedback and guidance to colleagues.
Support the development, review, and updating of SOPs, study documentation, and data management processes.
Stay informed about emerging data management technologies and identify opportunities to improve processes and operational efficiency.
Ensure services meet the specifications defined in Data Management Plans (DMPs) and agreed scopes of work.
Maintain accurate records of activities and support internal and client audits, addressing findings and comments within appropriate timelines.
Represent Data Management in business development activities, including bid defense meetings, and help identify solutions that address sponsor needs.
Promote Biometrics services and contribute technical expertise to departmental strategy and continuous improvement initiatives.
Perform other related responsibilities as assigned.
The successful candidate will bring extensive clinical data management experience, strong oncology knowledge, and a proven ability to lead teams and manage sponsor relationships. Required qualifications and skills include:
University or college degree. Relevant education and professional experience may be accepted as an equivalent to a bachelor's degree.
At least 8 years of combined early- or late-stage clinical data management experience.
Minimum 2 years of direct sponsor management experience.
At least 2 years of technical mentoring experience.
Demonstrated experience in oncology clinical trials.
Proven ability to manage customer negotiations, scopes of work, and project budgets.
Thorough knowledge of clinical trial processes, data management, clinical operations, Biometrics, and supporting systems and applications.
Strong understanding of the CRO industry and its regulatory and operational relationships with pharmaceutical and biotechnology companies.
Experience leading project strategies, achieving departmental objectives, and encouraging teams to identify and implement solutions.
Ability to manage competing priorities, meet project timelines, and work within productivity expectations.
Strong organizational, communication, interpersonal, and problem-solving skills.
Ability to collaborate effectively with colleagues and provide subject matter expertise and guidance to junior team members.
Experience representing Data Management in bid defense meetings and proposing solutions tailored to client requirements.
Fluency in English, including speaking, writing, and reading.
A degree in Life Sciences, Health Sciences, Information Technology, or a related discipline is preferred.
Four or more years of Electronic Data Capture (EDC) experience is preferred.
Familiarity with the organization's structure and SOPs is an advantage.
Ability to work remotely using computer-based systems for extended periods, with awareness of potential eye strain and repetitive strain associated with screen and keyboard use.
Annual salary range of CAD 110,000–120,000.
Comprehensive benefits eligibility for regular full-time or part-time employees working at least 20 hours per week.
Medical, dental, and vision coverage.
Life insurance.
Short-term and long-term disability coverage.
401(k) retirement savings plan.
Paid Time Off (PTO) or Flexible Time Off (FTO).
Company bonus, where applicable.
Fully remote working arrangement.