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Senior Clinical Trial Manager

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Date: Sep 9, 2021

Location: Boston, MA, US

Company: Terumo BCT, Inc.

Requisition ID:  27678  

 

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

 

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.

 

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential. 

JOB TITLE: Sr. Clinical Trial Manager, Global Clinical Operations

 

JOB SUMMARY

Manages projects and project teams to implement and operate both pre- and post-market clinical trial(s) and real-world evidence collection in the US and globally.  Develops or assists with development and ensures adherence to study budget and timelines.  Ensures compliance with the Clinical Investigation Plan (CIP), applicable regulations, and established SOPs/processes.  Recommends and implements innovative process ideas to positively impact clinical trial  management and clinical trial team management.  Manages vendors required to efficiently execute and complete clinical studies, effectively drives performance to ensure timelines and goals are met.  Provides leadership, coaching, mentoring and training to study team members as well as liaise with cross-functional department personnel. Represents Clinical Operations on design and life-cycle management teams as needed. Maintains and applies a thorough understanding of GCP/ICH/ISO regulations. 

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

 

  • Manages and provides leadership for the clinical trial team’s direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives
  • Develops or assists in the development of study budgets and manages and ensures adherence to overall study and site budgets
  • Develops and manages timelines for clinical studies
  • Manages the operational aspects of clinical trials including but not limited to budgets, contracts,  document development and review, investigator recruitment and site selection patient enrollment, trip report review, study trackers, and study specific guidelines/processes, Trial Master File and document management, data capture, review, and approval, closeout visits and reports
  • Author and/or edit, ensuring completeness and accuracy of content of Clinical Trial documents such as Clinical Investigation Plans, Informed Consent Form templates, Case Report Forms, Statistical Analysis Plans, Clinical Project Plans, Study Management and Monitoring Plans, Clinical Investigation Reports, training materials, contracts, etc. ensuring quality, consistency, management, and adherence to established regulations/processes
  • Act as primary contact for study team members and managing external vendors, providing training, guidance, and mentoring to study team members and may provide back-up coverage to other Clinical Trial Managers
  • Conduct or participate in study site visits, as necessary
  • Coordinate investigator meetings as needed; prepares presentation materials and presents project information at internal and external meetings (eg, study site, vendors)
  • Assures quality and integrity of clinical trial data by monitoring subject status during the course of the study. Assures quality of data collection and alert of applicable personnel if safety or study conduct issues are identified.   Assures that monitoring visits are scheduled at appropriate time intervals and adjusted to manage various patient accrual rates.  Assures that CRAs manage sites to ensure timely, accurate collection of data and query resolution.  Tracks data query rates; identifies and provides solutions for data trends
  • Partner and coordinate efforts of cross-functional project members to ensure efficient communication and implementation of projects

 

OTHER ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Contributes to the preparation of relevant clinical sections for regulatory documentation, such as IDE, IND, or CE-Mark Technical Dossier ,510k, PMA, and NDA.
  • Coordinates the investigation and verifies reports of serious/unanticipated drug or device related adverse events, device deficiencies, and protocol deviations and ensures follow-through, resolving and/or escalating study-related issues in a timely fashion
  • Participates in internal and external audits to monitor and identify improvement opportunities within Clinical Affairs
  • Works closely with KOL’s to plan clinical programs and resolve clinical related issues.
  • May work with management team to define clinical program strategies that support business areas objectives
  • May assist management team in determining resource requirements to support effective implementations and outcomes of studies
  • May liase with Program Management to ensure study budgets and timelines are aligned with product life cycle management and I&D goals and budgets
  • May represent Clinical Operations on design teams and life-cycle management teams as needed

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

Bachelor’s degree in nursing or biological sciences or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

  • Advanced degree preferred

 

Experience

  • Minimum 6 years experience and/or training in managing clinical trials, one of which includes leading global clinical trials or global project management
  • Experience conducting all phases of multi-center clinical trials either in medical device, diagnostic, or pharmaceutical industry
  • Knowledge of clinical study (GCP) and good working knowledge of regulatory requirements (ISO, FDA, ICH), both US and International

 

Skills

  • Demonstrated effective leadership, management, cross-functional team skills, self-direction, and ability to work independently
  • Has a thorough understanding of applicable GCP, CFR, ISO regulations
  • Demonstrates ability to function independently and cooperatively, and exercises judgment in developing methods, techniques and evaluation criteria for obtaining solutions and resolving problems
  • Ability to work in a matrix environment managing several projects
  • Must have a positive and proactive approach to identification and definition of problems, leading to proactive development and implementation of solutions 
  • Requires a high level of adaptability, initiative, and willingness to take ownership and accept responsibility for actions and decisions of the team

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

PHYSICAL REQUIREMENTS

Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

 

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

 

 

Target Pay Range:  $95,500.00 to $119,400.00 -  Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base:  10.0

 

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

 

We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.


Nearest Major Market: Boston

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