Pharm-Olam, LLC

Associate Director, Clinical Operations, GCO, The Americas (Open throughout North America)

Job Locations US-TX-Houston | US | US-NC-Raleigh-Durham | CA | US
Job ID
2021-2766
Category
Clinical Operations

Overview

About Pharm-Olam, LLC: 

Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) that has 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: 

The Associate Director, Clinical Operations, GCO, North America, will Lead CRAs and CTAs 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

 

This is a full-time direct hire opportunity for a professional Clinical Operations Leader with experience working at a small to midsized CRO. Ideal candidates should have a combination of Team  & Departmental Management experience and reside within the US or Canada. #LI-Remote

Responsibilities

 Department Management

  • Generate and submit monthly reports to Department Head.
  • Contribute to GCO Meetings.
  • Attend Project Meeting Reviews as needed.
  • Escalate any appropriate issues to Department Head 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.
  • Contribute and Participate in Internal Projects to improve process or develop new business practices.

 CRA Management

  • Line management of CRAs:
    • Conduct 121 Calls or Meeting
    • Document 121 Calls following PO process
    • Conduct Appraisals, Mid-Year and End-of-Year Reviews following PO process
    • Oversight the process to ensure Site Visit Reports and Follow-up Letters are drafted and completed on time and quality
  • Ensure CRAs work following Pharm-Olam SOPs, Working Instructions and Study Specific Processes.
  • Propose process to ensure CRA professional development for current CRAs and potential external candidates through the CRA Academy.
  • Propose policies to ensure CRA engagement.
  • Contribute within the 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 if Project Teams requests support.

Local CTA Management Oversight

  • Oversight a Manager having Local CTAs as direct reports.
  • Organize CTA Line Managers who will manage and oversight Local CTAs to ensure individual Local CTA performance within assigned projects.

Local CTA Management

  • Line Management of CTAs:
    • Conduct 121 Calls or Meeting
    • Document 121 Calls following PO process
    • Conduct Appraisals, Mid-Year and End-of-Year Reviews following PO process
    • Oversight the process to ensure Site Visit Reports and Follow-up Letters are drafted and completed on time and quality
  • Ensure CTAs work following Pharm-Olam SOPs, Working Instructions and Study Specific Processes.
  • Propose process to ensure Local CTA professional development.
  • Propose policies to ensure Local CTA engagement.
  • Contribute within the 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.

Country Knowledge Management

  • Maintain ongoing awareness of developments with the clinical development field.
  • Engage with external stakeholders involved in Clinical Trials execution.
  • Ensure Country Readiness in those Therapeutics Areas Pharm-Olam focuses on.
  • Support Project Teams with Site Selection and Recruitment Strategies in the Country.

Support to Business Development and Proposals

  • Interacts with Business Development in presenting the Pharm-Olam capabilities in the Country.
  • 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:

 

  • Typically reports directly to Executive or Senior Director, Clinical Operations, GCO.
  • 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 8 years' relevant clinical research experience in a pharmaceutical and/or CRO industry environment leading site activation, CRA and trial support teams.
  • Strong direct Line Management experience
  • 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 business needs.

For Consideration

 

Please apply online at www.pharm-olam.com/careers

 

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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