Summary
Overview
Work History
Education
Skills
Certification
Language
Affiliations
Timeline
Generic

Mark M. Koscin

Flemington,NJ

Summary

Dynamic Senior Manager with a proven track record, excelling in training and development. Expert in organizational improvement and budget oversight, I drive performance metrics and foster talent development. Passionate about enhancing team capabilities, I create innovative training programs that elevate clinical operations and ensure compliance with industry standards.

Overview

20
20
years of professional experience
1
1
Certification

Work History

Senior Manager, Clinical Operations, Training and Development

ClinChoice
11.2021 - 07.2024
  • Responsible for developing and delivering an industry leading training strategy and design staff and investigational site staff participating in clinical trials.
  • Sets performance metrics, evaluates productivity, identifies and arranges training initiatives and helps employees create long-term career plans within Clinical Operations.
  • Assist Clinical Operations management with day-to-day operations including line management of CRAs and PMs, allocation and utilization, budget development and negotiations, bid defenses etc.
  • Facilitate the overall training needs assessment with the team to define training plan with clear learning objectives.
  • Conducts annual training such as in areas of anti-corruption, fraud, and other training needs identified by senior/executive management and development needs assessments.
  • Conducts new hire training/onboarding for Clinical Operations personnel.
  • Conducts follow-up studies of all completed training to evaluate and measure results.
  • Develop training programs for Clinical Research Associates (CRAs) who are new to clinical research.
  • Develop multimedia visual aids and presentations.
  • Develop training and development programs and objectives.
  • Design and develop innovative comprehensive curriculum utilizing advanced design/development techniques and tools of adult learning.
  • Create testing and evaluation processes.
  • Assist with the design, development and implementation of performance metrics and processes; including assisting with the establishment of competency models for various positions in the company and provide guidance to managers on methods to assess the competency of employees.
  • Accompany and perform on-the-job co-monitoring training with new Clinical Research Associates for all types of visits (Site Selection – SEV, Site Initiation- SIV, Interim Monitoring – IMV, and Close-out visits (COV) to ensure the CRA has the competencies to monitor sites independently.
  • Sign off on all training visits when the individual has passed each milestone.
  • Work with Quality Assurance and Human Resources to develop a plan to track training activities per employee (i.e.,SharePoint).
  • Observes internal and external meetings and provide feedback and coaching required for Project Managers, Clinical Team Leaders, CRAs etc., to help them become more effective leaders.
  • Obtains and / or develops effective training materials utilizing a variety of media.
  • Trains and coaches' managers, supervisors and others for employee development efforts.
  • Plans, organizes, facilitates and orders supplies for employee development and training events.
  • Modifies programs as needed in accordance with all applicable regulations and organizational procedures.
  • Exemplifies the desired culture and philosophies of the organization.
  • Works effectively as a team member with other members of management.
  • Train new investigators and their staff members as required.
  • Participate in developing budget and proposal writing.
  • Participate in KPI setting and project risk assessment.
  • Participates in program allocation and resourcing.
  • Periodically participate in “SWAT” team activities for rapid study start up or close-out as required.

Senior Clinical Operations Associate

Taisho Pharmaceutical R&D, Inc.
09.2017 - 05.2021
  • Reporting directly to the Director, Clinical Operations retaining responsibility for training and regulatory compliance, review of outsourced contracts, and manage outsourced vendors.
  • Duties also include review of all study documents from protocols and work process documents and data review, TMF review maintenance and TLF review.
  • Registers and manages webinar training sessions.
  • Worked to develop Sponsor Oversight Program.
  • Reviews AE/safety reports and generates queries.
  • Responsible for quality of the Central Files for each study.
  • Review, track, and comment on monitor site visit reports.
  • Performs co-monitoring visits to evaluate CRO monitor performance.
  • Participates in SOP development.

Principal Clinical Research Associate

PPD
12.2011 - 08.2017
  • Currently working as a Principal CRA on a Phase III multicenter study evaluating patients presenting for non-small cell lung cancer.
  • Monitor investigator sites, with particular ability to manage complex studies and/or challenging sites, to ensure the accuracy and validity of CRF entries.
  • Recommend processes to Clinical Management that optimize the use of project resources.
  • Provide mentoring and support to less experienced members of the project team and advice on training and quality issues.
  • Assist colleagues with site visits and site calls, when needed.
  • Serve as a resource to team members with protocol, source document, CTMS, regulatory, data entry, and query resolution questions and issues.
  • Serve as the primary contact with individual investigative sites that conduct clinical research for PPD.
  • Track enrollment status reports to ensure study stays on track to meet enrollment goals.
  • Track study-specific status reports to ensure all required information regarding site issues, deviations, and CRF status were kept current by the monitoring team.
  • Serve as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues.
  • Provide direct support to the Clinical Team Manager by assisting with monitoring visit report review and other managerial tasks.
  • Perform study-specific training with project team.
  • Develop study-specific monitoring tools and forms for use by monitoring team to assist in efficient review of study data.

Adjunct Faculty

The State University of New Jersey Rutgers College of Nursing, Center for Professional Development
10.2004 - 09.2016
  • Perform Serious Adverse Event reconciliation and work with sponsor, study sites and CRAs to resolve discrepancies.
  • Review outstanding data reports and work with CRAs to ensure data collection is met per contractual guidelines.
  • Assist sponsor, study sites, and CRAs with audit preparation/responses and quality issues.
  • Attend sponsor calls and internal team calls to stay informed of current study issues.
  • Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices.
  • Conduct site visits to determine protocol and regulatory compliance, and prepared required documentation.
  • Develop collaborative relationships with investigative sites, client company personnel and study vendors.

Education

Graduate Certificate Course - Advanced Clinical Research, Clinical Trails Management

Sollers College
Menlo Park, NJ
11.2021

Medical Technologist, MT - undefined

University of the Uniformed Health Sciences
Portsmouth, VA

EMT-A -

Coastal Carolina Community College
Jacksonville, NC

Combat Medicine Training - undefined

Field Medical Service School
Jacksonville, NC

Basic Hospital Corpsman - undefined

University of the Uniformed Health Sciences
San Diego, CA

Skills

  • Reporting oversight
  • Business performance management
  • Cross-functional communication
  • Budget oversight
  • Influencing and negotiating
  • Organizational improvement
  • Troubleshooting and problem resolution
  • Organizational development
  • Cross-functional collaboration
  • Talent development
  • Documentation and reporting
  • Cross-functional team coordination
  • Data-driven decision making
  • Cross-functional team leadership
  • Reporting management
  • Budget administration
  • Verbal and written communication
  • Negotiation
  • Training and development
  • Team building
  • Problem-solving
  • Team leadership
  • Staff management
  • Budget management
  • Crisis management
  • Talent acquisition
  • Risk management
  • Teamwork
  • Process improvement
  • Needs assessment
  • Performance evaluation
  • Computer skills
  • Negotiation and conflict resolution
  • Team development
  • Multitasking Abilities
  • Managing operations and efficiency

Certification

  • Certified Clinical Research Associate, Association for Clinical Research Professionals, 2007-04-01, Present
  • NYC Board of Health – Medical Technologist, Expired
  • Basic Life Support, American Heart Association, Expired, 2012
  • Advanced Cardiac Life Support, US Navy, Expired
  • Advanced Trauma Life Support, US Navy, Expired

Language

English
Native

Affiliations

  • Association of Clinical Research Professionals (ACRP), 1997
  • ACRP Global Ethics Committee
  • ACRP Lead Forum Chair
  • ACRP Marketing and Communications
  • ACRP Project Managers Forum Chair
  • Essex Institutional Review Board Consultant
  • ACRP Project Managers Forum Track Chair

Timeline

Senior Manager, Clinical Operations, Training and Development

ClinChoice
11.2021 - 07.2024

Senior Clinical Operations Associate

Taisho Pharmaceutical R&D, Inc.
09.2017 - 05.2021

Principal Clinical Research Associate

PPD
12.2011 - 08.2017

Adjunct Faculty

The State University of New Jersey Rutgers College of Nursing, Center for Professional Development
10.2004 - 09.2016

Medical Technologist, MT - undefined

University of the Uniformed Health Sciences

Combat Medicine Training - undefined

Field Medical Service School

Basic Hospital Corpsman - undefined

University of the Uniformed Health Sciences

Graduate Certificate Course - Advanced Clinical Research, Clinical Trails Management

Sollers College

EMT-A -

Coastal Carolina Community College

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