Innova Solutions has a client that is immediately hiring for a Study Management Manager.
Position type : Full-time - Contract
Duration : 12 Months
Location : R emote
As a Study Management Manager, you will :
Description
Biosimilars – Manager Study Management (Biosimilars – MSM)
Purpose :
- Primary point of contact to lead, manage and coordinate, in partnership with the Contract
- Research Organization (CRO), the conduct of clinical trials from study design to close out at a global level in accordance with ICH-GCP
- Oversee the quality and scientific integrity of clinical operations for studies at a global level
- Collaborates with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables
Responsible for :
Global biosimilar development operational execution through oversight of cross functional trial activities in partnership with CROEnsuring implementation of trial(s) in partnership with CRO in accordance with applicable SOPs and ICH / GCP guidelinesExecution of clinical studies with high-quality, on time, and within budgetContribute to the authoring and review of key study documentsDay to day management of study execution including management of study timelinesManaging program-level operational issues and oversight of study team issue escalationSupports / Leads the Global Clinical Study Team for the allocated program(s)Communicating global status of clinical study programs to senior managementContributing to initiatives and process improvement work streams, including process mapping of CROsKey Activities :
Leads or supports the execution of all studies for a biosimilar program. Includes, but not limited to, PK / PD studies, global pivotal studies,chart reviews, region-specific studies, and device studies as appropriate
Oversee the development of study timelines and budgets for studies within a biosimilar programLeads or co-leads (with Clinical Data Management) a cross functional team to review clinical study data to ensure high quality deliverables from the CROReview and contribute to the creation of study documents, eg, synopsis, protocols, study plans, and Clinical Study Reports (CSR)Contribute to the execution and oversight of the feasibility process including the development of the site listParticipate in the set-up of study vendors including development of process flow, scopes of work, and budget reviewFor clinical logistics managed by Client, contribute to the overall study drug management including management (if applicable) of reference product, pre-medications, and other supportive medications / devices. For outsourced clinical logistics, contributes, in collaboration with the CRO, for the overall study drug management including management (if applicable) of reference product, pre-medications, and other supportive medications
Support global recruitment forecasting, global enrolment, and any recruitment enhancement initiativesIn partnership with the CRO, help organize investigator meetings and study training (eg, CRA training)Contribute to inspection readiness activities (eg, TMF review, story board generation)Supports internal audit and regulatory agency inspection readiness activities (eg, TMF review)Supports / Leads the GCST, ensure operational consistency and standards across all clinical studies within a biosimilar programIdentification and resolution of cross-functional study / program issues within a biosimilar program or escalated from the CROEnsure timelines and deliverables are communicated cross functionally and at the CROCommunicate study status to managementContribute to development and maintenance of policies, SOPs, and associated documentsRepresent the function by contributing to initiatives for the continuous improvement of clinical study executionOutputs :
Day-to-day oversight of study start up / execution / close out activities in partnership with CRO and third-party suppliersAlong with the CRO, study-related documents, plans, site lists and timelinesPresentations to management and external audiences (when appropriate)Recommendations for process improvement initiativesBasic Qualifications
Bachelor’s degree & 5 years of directly related experience OR Master’s degree & 3 years of directly related experience OR Doctorate degree & 2 years of directly related experienceExperience with oversight of clinical research organizations (CROs)Experience in leading cross-functional teamsPreferred Qualifications
7-9 years’ work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)Experience in oversight of outside vendors (CROs, central labs, etc)Knowledge
Knowledge of relevant therapeutic or product areaClinical research experience obtained working on industry-sponsored global clinical trialsExcellent oral and written communication skillsProven ability to lead, manage, and motivate others in a complex, multi-functional environmentExperience working in a global, matrix organization on global clinical development programsKnowledge to represent and evaluate strategies for clinical development and to critically evaluate outside expert adviceBroad knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements / guidelinesSolid understanding of Biopharmaceutical / Healthcare ComplianceProven ability to anticipate and resolve problemsExcellent interpersonal and organizational skillsProfessional collaboration and leadership skillsExperience anticipating and resolving problemsExperience writing and presenting clearly on scientific and clinical issuesExperience collaborating and leading cross-functional teamsTop 3 Must Have Skill Sets :
o Comfortable navigating ambiguity; be able to assume ownership of a task with limited guidance (i.e., come to me with questions, but don’t necessarily expect “hand holding”)
o I would like to see linear progression with increasing responsibility in roles
o Experience working for a Sponsor (eg, working for pharmaceutical / biotech company) and for Contract Research Organizations (CROs).
At the task level, the ideal candidate will have experience in the following activities :
Informed Consent Form (ICF) review
Sample management / tracking
eTMF (Trial Master File) experience
data listing / patient profile review; ability to work with data management
Inspection readiness / support activities
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!
Pradip Joshi
Email - Pradip.Joshi@innovasolutions.com
Phone : 213-401-2633
PAY RANGE AND BENEFITS :
Pay Range
55- $60 / HrPay 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 :
Named One of America’s Best Employers for New Grads by Forbes (2024Named One of the Best Companies to Work For by U.S. News & World Report (Private Companies List, 2024-2025)One of the Largest IT Staffing Firms in the US – Ranked #3 by Staffing Industry Analysts (SIA, 2024)One of the Largest Staffing Firms in the US – Ranked #13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics)Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024)AWS Advanced Tier Services Partner with 100 certificationsWebsite : 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.
Salary : $55 - $60
