Pharm-Olam, LLC

Executive Director, Global Clinical Operations (GCO)

Job Locations US-TX-Houston | US-NC-Raleigh-Durham | US
Job ID
2021-2771
Category
Clinical Operations

Overview

About Pharm-Olam, LLC: 

Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) with a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.

 

Summary: 

Oversees and manages global clinical operations activities to ensure quality and timely performance of all investigational site activities (activation, management and visits) and study file management for clinical studies conducted by Pharm-Olam globally. Ensures adequate resources and training of all clinical personnel.  Provide direct line supervision of local Clinical Operations staff and support to these individuals on a day to day basis. 

 

This is a full-time direct hire opportunity that is being recruited for throughout the US. Position can be remote. #LI-Remote

Responsibilities

Leadership

  • Lead GCO in North America to be the Operational Team of choice for Principal Investigators and Sponsors by providing best in class operational staff to deliver clinical trial success by a commitment to quality standards, ease of working and ready to embrace innovation to optimize our processes.
  • Other responsibilities as required.

 

Department Management:

  • Generate and submit monthly reports for senior management on Global Clinical Operations activities.
  • Conduct GCO meetings on a regular basis with GCO Managers and Operational Staff
  • Attend Project Meeting Reviews as needed.
  • Escalate any appropriate issues to senior management to ensure quality is met and actions are monitored until resolution is agreed and met.
  • Oversight Quality topics – Inspections and External and Internal Audits – ensuring quality responses to each case action demanding GCO contribution.
  • Review and identify training needs for GCO Staff and ensure Training Compliance for all GCO Staff
  • Provide continuous evaluation of Global Clinical Operations processes to identify and address strengths and weaknesses to maintain competitive advantages.
  • Maintain ongoing awareness of developments with the clinical development field.
  • Contribute with control approved budget

 

Line Management

  • Line Manager all direct reports (Managers)
  • Define process to ensure GCO Manager professional development

 

CRA Management:

  • Organize CRA Line Managers (Clinical Research Managers) who will manage and oversight CRAs to ensure individual CRA performance within assigned projects
  • Oversight the process to ensure Site Visit Reports and Follow-up Letters are drafted and completed on time and quality
  • Define process to ensure CRA professional development for current CRAs and external candidates through the CRA Academy
  • Define policies to ensure CRA engagement
  • Define process to ensure an effective CRA recruitment process to ensure quality of the selected candidates
  • Manage the monthly CRA Allocation process to projects to ensure a quality MAF every month and weekly updates whenever needed
  • Deal with internal stakeholders and clients to allocate CRAs to projects
  • Resolve client-face conflicts with CRA allocations

 

Local CTA Management:

  • Organize Local CTA Line Managers (Clinical Research Managers) who will manage and oversight Local CTAs to ensure individual Local CTA performance within assigned projects
  • Define process to ensure Local CTA professional development
  • Define policies to ensure Local CTA engagement
  • Define process to ensure an effective Local CTA recruitment process to ensure quality of the selected candidates
  • Manage the monthly Local CTA Allocation process to projects to ensure a quality MAF every month and weekly updates whenever needed
  • Deal with internal stakeholders to allocate Local CTAs to projects

 

North America Site Activation Management:

  • Organize the Site Activation Unit in North America to ensure a competitive performance (define as Site Evaluation Visit – Site Initiation Visit Turnaround) and year over year improvement
  • Review and upgrade Site Activation Processes to ensure site activation effectiveness and performance
  • Ensure engagement with external key stakeholders in site activation in US
  • Define process to ensure an effective Site Activation Staff (Site Activation Lead, Local Site Activation Officers – IRBs & Essential Documents and Local Site Activation Officers – Contracts & Budgets) recruitment process to ensure quality of the selected candidates
  • Manage the monthly Site Activation Staff Allocation process to projects to ensure a quality MAF every month and weekly updates whenever needed
  • Deal with internal stakeholders to allocate Site Activation Staff to projects
  • Resolve client-face conflicts with Local CTAs allocations

 

Feasibility Management:

  • Organize and oversight the Feasibility process in North America working together with the Global Feasibility Unit

 

Support to Project Execution:

  • Ensure GCO Staff work following Pharm-Olam SOPs, Working Instructions and Study Specific Processes
  • Support Project Teams with Site Selection and Recruitment Strategies

 

Support to Business Development and Proposals:

  • Interacts with Business Development in presenting the company and capabilities.
  • Participate and contribute to prepare value propositions for potential clients.
  • Participate and attend to Bid Defence Meeting (support for preparation and attendance).
  • Attend Conferences as requested by Business Development to promote Pharm-Olam services

  

Working Relationships:

  • Report directly to VP, Global Clinical Operations
  • Member of the GCO Leadership Team
  • Line management of appropriate staff including GCO Managers
  • Collaborate with all Operational and Non-Operational Departments within Pharm-Olam
  • Collaborate with the Pharm-Olam senior management
  • Liaise with external stakeholders such as sponsors, investigators, networks, Central IRBs, and service vendors.

Qualifications

  • Bachelor's degree or combination of education and experience
  • Minimum 15 years' relevant clinical research experience in a pharmaceutical and/or CRO industry environment leading site activation, CRA and trial support teams
  • Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
  • Computer skills including proficiency in use of Microsoft Office, CTMS, eTMF and ERP
  • Effective Leadership
  • Ability to proactively identify and resolve issues in a timely manner.
  • Effective oral and written and presentation communication skills, with the ability to communicate effectively with medical personnel.
  • Effective organizational and time management skills.
  • Ability to manage multiple projects and strong attention to detail.
  • Ability to establish and maintain effective working relationships senior management, peers, direct reports and clients.
  • Mature management skills demonstrated by calm and thorough review of situations. 
  • Seeks to understand all contributing factors - Proposes, implements, and evaluates appropriate resolutions.
  • Proven flexibility and adaptability.
  • Ability to work in a team or independently and to effectively prioritize tasks.
  • Strong customer service orientation.
  • Ability to perform travel an average of 30% of working time, depending on project needs.

For Consideration

Pharm-Olam, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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