Clinical Data Manager
Spectraforce
Sylmar, California
a day ago
Job Description
Title: Clinical Data Manager
Location: Sylmar, CA 91342
Duration: 6-month with potential to extend, highly likely
Position Summary:
The Clinical Data Manager is responsible for managing the development, documentation, and execution of risk-based quality management systems, as described in the risk assessment, data management plan, and site and central monitoring plans. As the customer face of Data Review and its primary liaison with the therapy group, the Clinical Data Manager's therapy-specific knowledge ensures alignment to customer definitions of criticality and informs review and analysis of study data.
Background & Context:
This position for a Clinical Data Manager will oversee 3-5 clinical trials from data management perspective, and together with assigned Coordinator, takes care of all related activities from CRF design, clinical data review and oversight, to trial closure related data activities.
Key Responsibilities:
Qualification & Experience:
Experience Details:
Language Proficiency: English
About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $42.00/hr.
Location: Sylmar, CA 91342
Duration: 6-month with potential to extend, highly likely
Position Summary:
The Clinical Data Manager is responsible for managing the development, documentation, and execution of risk-based quality management systems, as described in the risk assessment, data management plan, and site and central monitoring plans. As the customer face of Data Review and its primary liaison with the therapy group, the Clinical Data Manager's therapy-specific knowledge ensures alignment to customer definitions of criticality and informs review and analysis of study data.
Background & Context:
This position for a Clinical Data Manager will oversee 3-5 clinical trials from data management perspective, and together with assigned Coordinator, takes care of all related activities from CRF design, clinical data review and oversight, to trial closure related data activities.
Key Responsibilities:
- Identification of study specific risks to study conduct and human subject safety; analysis of risks; development and implementation of mitigation strategies.
- Review of study data to detect anticipated and unanticipated issues related to trial data completeness and quality.
- Facilitate multi-stakeholder discussions to review findings, evaluate impact and develop action plans for correction and continued monitoring.
- Conduct Central Monitoring activities, as described in Central Monitoring Plan.
- Direct all data cleaning activity related to assigned studies.
Qualification & Experience:
- Education Level: Bachelors Degree
- Major/Field of Study: Biology, Health Sciences, Mathematics, Computer Science, or equivalent.
- Experience: Minimum 3 years in clinical operations or healthcare related field.
Experience Details:
- Education and work experience in project management, life sciences and/or technical field.
- Knowledge of data collection best practices for clinical trials.
- Knowledge of global clinical operations.
- Experience in consultative role, with Subject Matter Expertise, and effectively influencing a team decision to the desired outcome.
- Proficient at the identification of risks in a process, evaluation of likelihood and impact, and the development of effective mitigation and monitoring strategies that are imperfect yet meet the business need.
- Proficient in the translation of clinical trial requirements to the technical specifications required for effective data collection.
- Skilled at making inferences and connections based on limited information, clearly describing the knowns, unknowns, and alternative explanations.
- Intermediate project management skills; developing a multifaceted plan with complex dependencies and holding peers accountable to adherence to the plan while maintaining positive and collaborative relationships.
- Intermediate therapy specific knowledge of anatomy, physiology, pathophysiology, therapy and device.
- Licenses and Certifications: None required; Certified Clinical Data Manager (CCDM) or equivalent nice to have.
Language Proficiency: English
About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $42.00/hr.