Job Title: Study Mgmt Mgr - Biosimilars
Duration: 3 year
Location: Remote

Top 3 Must Have Skill Sets:

• 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”)
• Would like to see linear progression with increasing responsibility in roles
• 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

Job 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 CRO
• Ensuring implementation of trial(s) in partnership with CRO in accordance with applicable SOPs and ICH/GCP guidelines
• Execution of clinical studies with high-quality, on time, and within budget
• Contribute to the authoring and review of key study documents
• Day to day management of study execution including management of study timelines
• Managing program-level operational issues and oversight of study team issue escalation
• Supports / Leads the Global Clinical Study Team for the allocated program(s)
• Communicating global status of clinical study programs to senior management
• Contributing 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 appropriate
• Oversee the development of study timelines and budgets for studies within a biosimilar program
• Leads or co-leads (with Clinical Data Management) a cross functional team to review clinical study data to ensure high quality deliverables from the CRO
• Review 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 list
• Participate in the set-up of study vendors including development of process flow, scopes of work, and budget review
• For clinical logistics managed, 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 initiatives
• In 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 program
• Identification and resolution of cross-functional study / program issues within a biosimilar program or escalated from the CRO
• Ensure timelines and deliverables are communicated cross functionally and at the CRO
• Communicate study status to management
• Contribute to development and maintenance of policies, SOPs, and associated documents
• Represent the function by contributing to initiatives for the continuous improvement of clinical study execution

Outputs:

• Day-to-day oversight of study start up/execution/close out activities in partnership with CRO and third-party suppliers
• Along with the CRO, study-related documents, plans, site lists and timelines
• Presentations to management and external audiences (when appropriate)
• Recommendations for process improvement initiatives

Basic 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 experience
• Experience with oversight of clinical research organizations (CROs)
• Experience in leading cross-functional teams

Preferred 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 area
• Clinical research experience obtained working on industry-sponsored global clinical trials
• Excellent oral and written communication skills
• Proven ability to lead, manage, and motivate others in a complex, multi-functional environment
• Experience working in a global, matrix organization on global clinical development programs
• Knowledge to represent and evaluate strategies for clinical development and to critically evaluate outside expert advice
• Broad knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements/guidelines
• Solid understanding of Biopharmaceutical/Healthcare Compliance
• Proven ability to anticipate and resolve problems
• Excellent interpersonal and organizational skills
• Professional collaboration and leadership skills
• Experience anticipating and resolving problems
• Experience writing and presenting clearly on scientific and clinical issues
• Experience collaborating and leading cross-functional teams

Key Competencies

• Team leadership
• Strong written and oral communication
• Flexibility
• Initiative
• Problem solving
• Project management
• People management
• Decision making
• Scientific/technical excellence

Possible Extension: Yes
Interview Process: Video conference 
  
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 53.29/hr.