Job Title: Data Management Sr Mgr
Location: Remote
Duration: 1 year

Top 3 Must Have Skills:

• Transformational Knowledge – large projects with changes (Pharma Background)
• Risk Based Quality Management Experience
• ICH E6 knowledge
• At least 10 years Mgt experience – need a Data Management background.
• Knowledge of working with Data Mgt teams in a remote environment.
• Veeva Knowledge is preferred.

Job Purpose: 

• To provide expertise in data management processes, demonstrating capabilities & new ways of working, to assist in the design and implementation of both new technologies, new processes.

 
Job Description:
Clinical Trial Delivery Operating Model:

• Develop Data Management playbook to encompass new ways of working with key accountabilities defined and known, both internally within function as well as broader study team
• Assess and determine roles and responsibilities within the Data Management Team
• Cleansheet Data Management processes and identify areas for improvement in line with ICH E6 (R3), utilising technology to streamline efficiencies and reduce hand offs.
• Collaborate with cross-functional teams (clinical operations, site management, biostatistics, stats programming, TA) to optimize trial delivery.
• Deep understanding of Risk Based approaches and its impact with Data Management/Site monitoring operationally – consider the role of both Data Management and Site Management, Statistics and Analytics to layer to the model which will deliver studies with an appropriate risk-based approach, eg. reduced SDV etc
• Develop and document standard operating procedures (SOPs) for data management activities

Process Improvement:

• Analyze existing workflows and identify bottlenecks with new ways of working
• Implement best practices in data collection, cleaning, and reporting including knowledge of Pinnacle 21, Centralized Statistical Monitoring, Quality by Design, Risk-based Quality Management etc.
• Determine key performance indicators (KPIs) and suggest data-driven improvements
• Delivering a quality, fit for purpose dataset – plan, build, review with the end in mind (protocol – data collection – data review – analysis – archive)

New Technology Design and Implementation:

• Evaluate new data management tools and technologies (e.g., EDC systems, data integration platforms, data flow).
• Participate in system design, and user acceptance testing.
• Role model with staff on new technologies and ensure smooth integration into new and/or modified processes

Regulatory Compliance and Quality Assurance:

• Ensure all data management activities comply with regulatory standards (e.g., FDA, EMA, ICH-GCP)

Cross-Functional Collaboration:

• Collaborate with clinical teams to ensure data collection aligns with study objectives.
• Serve as a liaison between data management and other departments, facilitating effective communication with clear leadership and accountability.

Core Competencies:

• Technical Expertise: Deep knowledge of clinical data management processes and systems (e.g., EDC, CDISC standards, External Data Collection, eg eCOA, Central Labs etc). Familiarity with data visualization tools and data analysis techniques.
• Analytical Skills: Strong problem-solving skills with the ability to analyze complex data sets. Ability to interpret regulatory requirements and translate them into actionable processes.
• Project Management: Experience in managing projects, ensuring timely delivery and adherence to budgets. Skills in change management to effectively implement new processes and technologies. Experience with managing projects involving staff transitions between vendors
• Communication Skills: Excellent verbal and written communication skills for effective collaboration. Ability to present complex data and concepts to diverse audiences.

Experience & Knowledge:

• Minimum of 10 years of experience in clinical data management or related field.
• Proven track record of leading delivering on complex process improvement initiatives
• Ideally proven track record of delivering on complex technology implementations.
• Familiarity with Electronic Data Capture (EDC) systems (e.g., Veeva, Medidata).
• Knowledge of data visualization tools (e.g., Tableau, Power BI).
• Knowledge in statistical software (e.g., SAS, R) for data analysis.
• Knowledge, and ideally experience, of working with risk-based approaches (e.g. delivering studies using reduced SDV etc)

Basic Qualifications:

• Doctorate degree and 2 years of experience OR
• Master’s degree and 4 years of experience OR
• Bachelor’s degree and 6 years of experience OR
• Associate’s degree and 10 years of experience OR
• High school diploma / GED and 12 years of experience

Possible Extension: Yes
Red Flags: NA
Interview Process: Video Conference 

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
 
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: $70.00/hr.