Job Title : Senior Manager, Integrated Clinical Trial Data Process Excellence and Delivery
Duration: 11 months
Location: Cambridge MA

The Senior Manager, Process Excellence and Delivery supports the strategy to develop and maintain quality Global Integrated Clinical Trial Data Services (GICTDS) function processes for clinical trial data delivery, study reporting, and inspection readiness. They define processes to ensure complete, accurate, high quality, regulatory compliant data in support of publications and regulatory submissions.
In partnership with functional stakeholders and with Global Development Compliance, they contribute to and may lead within-function and cross-function process definition, training, and change management activities to successfully deliver the functional operational strategy.
Accountabilities:

• Support and may lead process design and governance for any of the following GICTDS functions: Clinical Data Management, Clinical Data Engineering, Clinical Data Standards, Clinical Trial Tools and Technologies, Risk Based Quality Management, Medical Writing, Information Management and Operational Systems, and Emerging Priorities and Innovation.
• Partner with Global Development Compliance (GDC) GCP Process Excellence to develop and implement these processes.
• Serve as functional process lead or business process owner delegate for a defined set of processes. Includes liaising with GDC on continuous process improvement, serving as process expert for end-users, and serving as point of contact for Quality related activities/initiatives.
• Collaborate with key stakeholders such as functional heads, business process owners, and clinical data system owners and product teams to support the implementation and maintenance of effective process(es) across the Network.
• Contribute to decision making to determine and clarify roles and responsibilities across functions and to determine how process responsibilities will be executed using clinical trial systems and technologies.?
• Contribute to development of new processes and technologies in compliance with quality standards (including ICH GCP, local regulations, and SOPs).?
• Monitor metrics and feedback from the global network and users to ensure the health of the process and performance against measures that are aligned with the organization strategies.?
• In partnership with GDC GCP Process Excellence, collaborate with both asset teams and leaders within Global Development Operations (GDO) to identify opportunities for improvement in clinical trial data delivery & study reporting processes including optimizing roles and responsibilities cross-functionally.
• Support clinical trial data delivery & study reporting process strategy based on external and internal perspectives to achieve GICTDS short-term and long-term goals.
• Develop solutions to complex problems which require the regular use of ingenuity and innovation. Ensures solutions are consistent with GICTDS objectives.

Education and experience:

• Bachelor's Degree or international equivalent required; Life Sciences preferred.?
• 6 or more years’ experience in the pharmaceutical industry or clinical research organization, including clinical data management/clinical trial data delivery & study reporting.
• 6 or more years of operational experience in clinical data management/EDC build and programming, IRT/eCOA implementation and management, data transfers/ingestion, centralized monitoring, and/or regulatory submission experience.?
• Understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, data management plans, clinical study reports) and processes.
• Understanding of clinical trial technologies, including EDC, IRT, eCOA, digital wearable tools, CTMS, TMF systems, centralized monitoring systems, and clinical study report generation tools.
• Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.
• Demonstrated matrix leadership and communication skills.
• Knowledge of FDA and ICH-GCP guidelines for conducting clinical research.
• Global/international experience preferred, including the ability to collaborate with team members in other locations.

 

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: $116.03/hr.