Specialist Study Management 28035 at American Cybersystems, Inc. in Wilmington, Delaware

Job Description:

Innova Solutions is immediately hiring a Specialist Study Management

Position type: Full time Contract

Duration:
12 months and possibility for extension

Location: Remote EST Time zone
Pay Rate Range: $35-$37

Qualifications:

• Level of education that supports Skills and Capabilities of the position and ensures
successful conduct of accountabilities/responsibilities and appropriate interactions
with internal/external customers, completed high school and further studies in
administration.
• Experience with vendor management, strong verbal & written communication skills,
and strong organizational skills
• Previous administrative experience
• Proven organizational and administrative skills
• Computer proficiency
• Very good knowledge of spoken and written English
• Display excellent organization and time management skills, excellent attention to
detail, and ability to multi-task in a high-volume environment with shifting priorities
• Team oriented and flexible; ability to respond quickly to shifting demands and
opportunities

Location- Remote (MUST be able to work EST time/hours)

As a Specialist Study Management , you will: • SSU CSA is responsible for ensuring vendor spreadsheets are completed correctly
and processed (submitted to vendor or global team) according to study team
guidelines.
• SSU CSA is responsible for reviewing and processing all sub Investigator
documents. SSU CSA will attend weekly Study Team meetings to report on vendor
spreadsheets, sub I document progression, etc. All responsibilities are performed
according to AZ Procedural Documents, international guidelines such as ICH and
GCP as well as relevant local regulations.
• A SSU CSA with longer tenure and experience may take on additional
responsibilities from the SSU Manager.

Typical Accountabilities
• Assist SSU Manager with obtaining and maintaining essential documents in
compliance with ICH-GCP, AZ Procedural Documents.
• Review and process start up documents, including Sub Investigator's documents in
compliance with ICH-GCP, AZ Procedural Documents
• Drive delivery of regulatory documents at the sites. Proactively identify delays in start-
up activities and the risks to the activation plan.
• Attend study team meetings and be prepared to provide a report on vendor spreadsheet
status and sub I document status.
• Set-up, populate and accurately maintain information in AstraZeneca tracking and
communication tools (e.g. Veeva Clinical, Box, etc.) and support others in the usage of
these systems

Skills and Competencies
REQUIRED:
1. Strong verbal & written communication skills
2. Strong organizational skills
3. Previous administrative experience
4. Computer proficiency

• Working knowledge of the Clinical Study Process and an understanding of the range
of working procedures relating to study Start-up, together with an understanding of
the ICH/GCP guidelines
• Ability to develop advanced computer skills to increase efficiency in day-to-day tasks
• Good interpersonal skills and ability to work in an international team environment
• Willingness and ability to train others on study administration procedures
• Integrity and high ethical standards

APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.

Thank you!

Deeksha Gupta
Team Lead - Recruitment
(+1) 213-788-7669
Deeksha.gupta@innovasolutions.com



PAY RANGE AND BENEFITS:

Pay Range*: $50-54.28 per hour
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.



Website: https://www.innovasolutions.com/

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.