Indiana Stem Jobs

Mobile Indiana Career Connect Logo

Job Information

DOCS Global Project Manager (Early Clinical Trial Development) in Indianapolis, Indiana

Global Project Manager (Early Clinical Trial Development)

Ref #: 24377

Employment type: Permanent - Full-Time

Location: US - Nationwide (home-based)

Posted: 30-Sep-2020

Description

Global Early Clinical Development Manager

If you have experience in Clinical Pharmacology, Phase 1 Dose Finding/Expansion, Digital/Mobile Health and Technology Evaluation and strong clinical trial management experience for early phase development, this is a great home-based opportunity.

Key Purpose

• Drives the management of operational activities related to planning, implementing, executing, and reporting of clinical trials

• Member of one or more cross-functional clinical study teams

• Core member of the Evidence Generation Team

Key Activities

Operations Planning & Execution

• Leads the study level planning and execution of overall operational deliverables, including study

level forecast of investigational products and study logistics plan through the CST ITL

• Develops the strategic scenarios of designs for early phase clinical development plan as part of the EGP generation

• Ensures standard processes, tools, and procedures are used consistently

• Routine engagement with Clinical Investigators

• Provide oversight, support the design, and manage operational activities related to the planning,

implementation, and reporting of outsourced Clinical Pharmacology studies

Study Oversight & Execution

• Leads, manages, and monitors overall study related activities including:

– Issues related to patient eligibility, enrollment and protocol deviations

– Ongoing safety data review and completion of study data collection, data lock, and

analysis

– Resolution of cross-functional study-specific issues

– Communication of study status to key stakeholder and updating relevant systems

– Ensures study personnel are appropriately trained and understand study timelines

and deliverables

– Manages study budget & communication of budget changes

• Drives the writing and/or review study design, synopsis, protocols, supplements, amendments and Investigational Product Instructional Manuals (IPIM)

• Contributes operational input to:

– Study related documentation, including safety and regulatory documents, Clinical

Study Reports, Case Report Forms, and other study-related documents

• Identifies site selection and feasibility in partnership with the Dev. Feasibility Manager

• Assists in selection, set up, and management of vendors, including invoice approval

• Organizes and leads investigator meetings where appropriate

• Drives and coordinates Dose Level Review Meetings (DLRMs) and ensures decisions are

effectively communicated, documented, and implemented

Inspection Readiness

• Supports internal & external audit and inspection activities and contributes to CAPAs globally

• Ensures study is inspection ready and executes related activities (e.g., TMF review, study history

document)

Preferred Qualifications

• MS, RN, or PharmD Degree

• 7+ years of experience in life sciences or medically related field

• 4+ years of bio-pharmaceutical clinical research experience obtained working on industry sponsored or industry-partnered clinical trials at academic institutions or working on clinical trials in a biotech, pharmaceutical or CRO company

• Management experience of direct reports

• Experience in oversight of Functional Service Providers, outside vendors (CRO’s, central labs,

imaging vendors, etc.)

Knowledge

• Advanced knowledge of first in human trials and early development study strategy & management

• Clinical trial processes and operations

• Extensive knowledge of ICH/GCP regulations and guidelines

• Project and Program management including oversight of study deliverable, budgets and timelines

• Time, cost and quality metrics, Key performance indicators (KPIs)

• Relevant Therapeutic knowledge

Competencies

• Matrix team leadership

• Project Management

• Problem solving

• Decision making

• Delegation skills

• Relationship Management and influencing skills

• Oral and written communication

• Time management

• Organizational and planning skills

• Ability to work effectively in a team/matrix environment on multiple projects

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

#GTMjob #PMjob

DirectEmployers