Sr. Clinical Study Manager (Remote)

Spectraforce Technologies Inc

Job Description

Job Title: Sr. Clinical Study Manager

Location: Northbrook, IL 60062 (Initially Remote)

Duration: 9 Months

Purpose and Scope

The purpose of the position is to plan, initiate, and execute clinical pharmacology studies, including those which are difficult/highly challenging to execute and/or of complex design, with operational excellence. The senior study manager is also accountable for budgets, timelines, and resources for CPED Operations. This position requires independent vendor management within studies and the training of and effective interactions with/coordination of study teams, vendors, and full-service outsourcing providers. The senior study manager participates in best-in-class initiatives to develop/improve global study execution standards, processes, and tools.

Operationalize scientific concepts including refining study design and providing feasibility assessment for complex study designs.

Lead cross-functional study teams in the operational planning, administration, and management of clinical pharmacology studies of any complexity, and/or collaborate with outsourcing provider in the execution of individual or packages of studies in compliance with Company SOPs, WPDs, BOGs, GCP/ICH, and other applicable regulatory requirements.

Outsource packages of CP studies. Supervise outsourcing providers in the execution of clinical pharmacology studies within governance.

Lead the development of GCPED deliverables for study planning, administration, management, and reporting. Collaborate with sites, vendors, and/or outsourcing partners to ensure operational excellence.

Requirements:

Bachelor's/Master's degree (or equivalent) with a scientific or clinical background, monitor experience preferred

Requires at least 3-4 years of operational experience in conducting clinical pharmacology studies.

Working knowledge of GCP, FDA and/or EU Clinical Trials Directive guidance documents

Experience with complex clinical pharmacology designs and drug development

Proven project management skills and study leadership ability

Excellent interpersonal, written, and verbal communication skills and computer ability

Fluent in English

Ability to analyze and explain complex study designs and when possible, recommend or implement improvements for operational efficiency and excellence; Innovatively obtain or apply resources to meet project goals.

In-depth knowledge/understanding of GCP, FDA and/or EU Clinical Trials Directive guidance documents, and Company guidance documents for clinical pharmacology studies and conceptual understanding of basic PK and/or PD for increased depth and breadth of input to clinical pharmacology study outline development, protocol design and feasibility assessment, and data reporting discussions, and for briefing document/IND/IMPD/NDA/CTD document review.

Ability to understand and apply appropriate steps for study budgeting, contracting, invoice & payment tracking, and quarterly forecasting. Ability to apply prior study costing experience to future study budget planning for assigned studies or packages of studies.

Problem-solving, critical thinking skills (i.e., Can Identify root cause and propose/implement reasonable corrective actions in the context of region-appropriate GCP regulations and guidance’s, Company SOPs, protocol, and industry best practices; Able to apply lessons learned from prior experience to novel challenges).

Decision-making skills (i.e., the Ability to provide on-the-spot decisions for complex problems, but consults with supervisor for feedback or escalation, if needed).

Proactive thinking skills (i.e., Can anticipate problems and take appropriate actions to avoid them).

Competent presentation skills (i.e., Verbal and visual presentations are logical, organized, accurate, and understandable).

Excellent writing skills (i.e., Concise, accurate, unambiguous style without typos and grammatical errors).

Excellent oral communication skills (i.e., Can describe experiences clearly and concisely and then if necessary provide details).

Highly motivated, self-directed (i.e., Ability to work independently); Follow through on commitments.

Organized and goal-oriented (i.e., Can independently break down and prioritize large tasks into achievable goals for completion. Can anticipate future project demands and plan accordingly. Aware of the status of tasks/milestones of assigned projects and delegated or outsourced activities; Does not lose track of critical details that could risk GCP/SOP/protocol adherence or project goals/costs/ timelines).

Job Requirements

Purpose and Scope

The purpose of the position is to plan, initiate, and execute clinical pharmacology studies, including those which are difficult/highly challenging to execute and/or of complex design, with operational excellence. The senior study manager is also accountable for budgets, timelines, and resources for CPED Operations. This position requires independent vendor management within studies and the training of and effective interactions with/coordination of study teams, vendors, and full-service outsourcing providers. The senior study manager participates in best-in-class initiatives to develop/improve global study execution standards, processes, and tools.

·         Operationalize scientific concepts including refining study design and providing feasibility assessment for complex study designs.

·         Lead cross-functional study teams in the operational planning, administration, and management of clinical pharmacology studies of any complexity, and/or collaborate with outsourcing provider in the execution of individual or packages of studies in compliance with Company SOPs, WPDs, BOGs, GCP/ICH, and other applicable regulatory requirements.

·         Outsource packages of CP studies. Supervise outsourcing providers in the execution of clinical pharmacology studies within governance.

·         Lead the development of GCPED deliverables for study planning, administration, management, and reporting. Collaborate with sites, vendors, and/or outsourcing partners to ensure operational excellence.

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