Senior Study Manager

AllSTEM Connections is seeking a Manager, Study Management - Biosimilars to work remotely in any US time zone.

Our confidential client is a global pharmaceutical company.

This is a 12-month contract position. Possible extension/temp-to-hire.

Hourly rate is open – client is open to market rates

M-F, 8AM - 5PM.

100% REMOTE

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-GCPOversee the quality and scientific integrity of clinical operations for studies at a global levelCollaborates 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 CROs

Key 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 appropriateOversee 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, e.g., 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 The Company, 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 medicationsSupport global recruitment forecasting, global enrolment, and any recruitment enhancement initiativesIn partnership with the CRO, help organize investigator meetings and study training (e.g., CRA training)Contribute to inspection readiness activities (e.g., TMF review, story board generation)Support internal audit and regulatory agency inspection readiness activities (e.g., 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 execution

Outputs:Day-to-day oversight of study startup/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 initiatives

Basic QualificationsBachelors degree & 5 years of directly related experience ORMasters degree & 3 years of directly related experience ORDoctorate degree & 2 years of directly related experienceExperience with oversight of clinical research organizations (CROs)Experience in leading cross-functional teams

Preferred Qualifications7-9 years' 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 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 teams