Clinical Project Manager

Hollister, Incorporated Located in: Libertyville,  Illinois
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Hollister, Incorporated Biotechnology Jobs Pharmaceutical Careers
 

JOB DESCRIPTION

SUMMARY:

The Clinical Project Manager is responsible for the execution of Clinical studies and ensures that they are carried out consistently with business strategies.  Interfaces with and reports progress to Sr. Clinical Management and business unit/corporate management.  Interfaces with key business stakeholders across several functions, including Marketing, Regulatory, Market Access, R&D, Clinical Operations, Clinical Data Management and Statistics.  Develops good working relationships with clinicians (physicians and nurses), other external research staff and external vendors.  Responsible for coordinating efforts for the study both within the Company and through a variety of vendors.

RESPONSIBILITIES

* With minimal supervision, plans and manages global clinical trials/studies within agreed-to budget, scope and schedule/timeline requirements.  Will be responsible and accountable for several concurrent clinical studies.

* Uses project management tools to build and communicate accurate study timelines and budgets

* Executes high quality, integrated cross-functional plans for the clinical study/trial. 

* Responsible for the execution of a clinical trial or suite of clinical trials from clinical protocol design to the final clinical study report. 

* Provides study updates to senior clinical management and to business unit/corporate management.

* Understands assigned study protocols and study data.

* Actively tracks study data analysis and publication activities.

* Ensures completion of timely clinical study reports for use by business world-wide (both internal and external customers: e.g., core teams, discovery teams, and regulatory submissions).

* Leads development of clinical study protocols along with clinical management and reviews/approves supporting documentation.

* Supports strong relationships with study sites and clinicians.  May review reports and support resolution of issues related to external sites as needed in support of clinical study activities.

* Leads clinical affairs team collaboration with business units and functional departments as well as collaboration within clinical affairs team (clinical operations, clinical experts, clinical data management and statistical team).

* Ensures regular review, summary and reporting of accurate clinical study progress to gatekeepers/stakeholders, project teams, regulatory and marketing teams throughout the course of a study.

* Contributes to relevant study documentation including clinical protocols, case report forms and clinical study reports.

* Proactively identifies study risks and works to mitigate them or create contingency plans.

CRITICAL REQUIREMENTS

  • * B.S. degree (relevant to position) and a minimum of 5 years of relevant experience

    * PMI (Project Management Institute) Certification a plus

    * Clinical project management track record with a working knowledge of project management tools and best practices (e.g., Microsoft Project)

    * Excellent communication skills, both written and verbal

    * Ability to progress a study with minimal guidance;  Initiative and drive for results

    * Experienced in managing global clinical trials and in leading a clinical study teams

    * Demonstrated understanding of creating and communicating an accurate clinical budget

    * Demonstrated ability to collaborate and interact effectively on a cross-functional team (represent Clinical Affairs)

    * Organizational, leadership, risk identification and problem solving skills

    * Experienced in protocol development, study management, and study reporting

    * Demonstrates an interest in and understanding of clinical developments and trends

COMPANY INFORMATION

Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets healthcare products and services worldwide. We offer advanced medical products for Ostomy Care, which includes two strong global brands – Hollister Ostomy and Dansac Ostomy; Continence Care; Critical Care; and Wound Care. We also provide innovative healthcare programs and services, as well as educational materials for patients and healthcare professionals. Hollister has been serving healthcare professionals and patients for more than 95 years — making a difference in the journey of life for people throughout the global community.

JOB INFORMATION

Seniority Level:
Experienced - Not Management
Function:
  Clinical Research / Affairs,  Operations,  Project Management
Preferred Industry Background:
  Medical Device,  Hospitals & Healthcare,  Biotechnology
Managing a team of:
N/A
Required Travel:
Moderate - 2 weeks per month

Base Salary:
Confidential
Bonus:
10%
Benefits:
Full Benefit package, 3 weeks vacation
Other Compensation:
Private Retirement Program
Education Required:
Any