Study Manager, Global Study Operations

Innova Solutions has a client that is immediately hiring for a Study Manager, Global Study Operations

Position type : Full time Contract

Duration : 12 months

Location :  San Rafael, CA (Remote)

As a(n) Study Manager, Global Study Operations you will :

Duties :

Responsibilities include but are not limited to :

Overall study execution oversight

Provide leadership, guidance, and direction to GSO staff assigned to studies

Lead cross-functional Study Execution Team (SET) meetings

Collaborate with cross-functional study members to drive and execute on study deliverables, documents, and plans

Proactively identify, manage, and communicate cross functional study issues, risks and mitigations in a timely manner

Provide regular study quality and progress updates to key stakeholders as needed

Monitor and act upon study metrics; review trend-identification and analysis and provide targeted follow up where appropriate

Collaborate with other Study Managers to ensure consistency and maintenance of the various study plans within a program

Collaborate with People and Process Managers of the Study Specialist staff to support team member productivity and career growth

Other responsibilities Include :

Contribute to the Study protocol and Informed Consent Form (ICF) development

Management of GSO Study Timelines

Management of CRO and Vendors

Management of Study Lifecycle (start-up, enrollment, maintenance and close-out)

Oversight of Drug / Investigational Product (IP) process

Management of Study Budget

Oversight of Feasibility, Recruitment and Enrollment

Oversight of Study Outcome and Data Deliverables

Lead or participate in program or study-specific projects that have a wider impact

Collaborate with study managers / cross-functional team members to implement department process change and efficiencies

This role can be either in house (San Rafael-based), hybrid, or remote.

Skills :

Within the role the candidate is expected to show and have proficiency and experience in the following competencies :

Core :

Decision Making and Problem Solving

Influence and Organizational Awareness

Agility and Proactivity

Leadership

Communication and Collaboration

Technical

Data Analysis and Interpretation

Study Management and Execution

Compliance and Quality

Drug Development and Study Design

Product and Therapeutic Area Knowledge

Knowledge of managing all phases of clinical trials (Early Clinical Development / Ph 1 through Post Approval studies)

Education : BA / BS / BSc

5 years’ work experience in life sciences or medically related field, including at least 3 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical, or CRO setting

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

We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines.   ASK ME HOW.

Thank you!

Namrata Gautam

PHONE : (+1) 314-523-1818

EMAIL : Namrata.Gautam@innovasolutions.com

PAY RANGE AND BENEFITS :

Pay Range

• 100- $130 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.

Recent Recognitions :

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.