Analyst , Study Start-Up Operations

Job Title: Analyst, Study Start-Up Operations
Duration: 12 Months
Location: Remote
Pay rate starts from $32/hr. (Negotiable)

Purpose:

• Describes the primary goals, objective or function, or outputs of this position.
• Clinical Development Operations Subject Matter Expert and support for clinical trial-related systems, with a focus on SSU activities.

Responsibilities:

• Supports SSU Business with maintaining customized Expected Document Lists, study-specific milestones, and study-specific tasks.
• Proactively identify and communicate issues impacting deliverables.
• Supports maintenance of ICF country templates, ISF templates, and Study Start-Up Package templates in Vault Clinical.
• Contributes to system enhancement requests and works with SSU Operations Management to assist with UAT and implementation.
• If assigned, triages and provides answers to stakeholder system-related questions.
• Provides input and/or recommendations to Work Instructions and Job Aids related to SSU systems.
• Participates in stakeholder SME and cross-functional meetings and maintains a positive working relationship with internal/external customers and colleagues.
• Provides suggestions and feedback to the line manager regarding issues or potential improvements and participate in functional area continuous improvement projects and/or work streams.
• If assigned, supports with organizing Team Meetings and minute taking.
• Provides audit and inspection preparation support for SSU-related deliverables and complies with GCP, Client SOPs, and functional area processes.

Qualifications:

• Bachelor's degree or international equivalent is highly preferred or equivalent years of experience are required.
• A minimum of 2 years of professional work experience; experience in the Pharmaceutical-related industry and study start-up experience preferred.
• Experience working with remote/virtual teams.
• Demonstrates analytical, critical thinking, and organizational skills.
• Ability to independently perform multiple tasks and projects at the same time.
• Good communication skills (oral and written) and proven effective, collaborative interactions with colleagues.
• Interpersonal skills with the ability to communicate with clarity, flexibility, and adaptability to changing requirements.
• Competent use of electronic systems. Experience using Vault eTMF or SSU preferred.
• Competent knowledge of clinical trial management systems and procedures.
• Competent use of Excel. Experience with SmartSheet preferred.

Below is the brief introduction of SPECTRAFORCE, the benefits we offer and the disclaimers:
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 130 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. Our entire workflow and teams are trained to cultivate the joy of NEWJOBPHORIA with candidates and employees throughout their engagement with SPECTRAFORCE.

Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, and hospital indemnity insurances. Additional benefits SPECTRAFORCE offers to the eligible employees include commuter benefits, 401K plan with matching and a referral bonus program. SPECTRAFORCE offers 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 nahr@spectraforce.com if you require reasonable accommodation.

Note: The Company 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.

Note: The Company is committed to complying with the California Consumer Privacy Act ("CCPA") effective January 1, 2020; and all data privacy and 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 . Applicants with disabilities may access this notice in an alternative format by contacting .