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Job Details

Clinical Team Leader (CTL) - US Based

Company: Pharm-Olam International
Location: US Regional, Home Based
Reference: CTL/USA
Closing Date: 17 Nov 16
Type: Permanent
Salary (£): Competitive
Benefits: Competitive Salary & Benefits

Job Summary:

Pharm-Olam International are a privately owned, mid-sized global Clinical Research Organization (CRO). With Headquarters in Houston, TX, Pharm-Olam has a global presence in over 40 Countries and since being established in 1994 Pharm-Olam have offered clients a wide range of comprehensive, clinical research services in phase I to phase IV trials. For more information about Pharm-Olam please visit our website,


Role: Clinical Team Leader (CTL)

Location: US Regional - Houston, TX or RTP, NC Preferred

Job Type: Permanent


About Pharm-Olam International:

With offices among the world’s most populated cities, Pharm-Olam International provides cost effective coverage for full service or strategic outsourcing across all therapeutic areas and phases of research. Since 1994 we have used our local knowledge of an investigator’s past performance, competing studies, and regulatory environment to offer sponsors an accurate and informed plan to complete trials on time.

For more information about careers at Pharm-Olam please visit our careers page:



The Clinical Team Leader (CTL) is responsible for management of Clinical portion of the study and will provide leadership and management to the Clinical Research Associates (CRA) and Lead Clinical Research Associates in global projects in clinical trial activities day to day for clinical projects including direct communication and interaction with investigative site/monitors. The CTL is responsible for managing the planning, implementation, and tracking of the clinical monitoring process. The position requires an active role in developing the plan and monitoring of both resource allocation and clinical trial so that all aspects of the plan are in progress.  


Key Responsibilities:

  • Manage the study start up in collaboration with PM and Regulatory Lead
  • Coordination and oversight of Critical documentation collection, maintenance and filing
  • Preparing Monitoring Plan 
  • Modifying visit reports according study specific requirements
  • Selection of investigators and sites; SEV report review and approval
  • Site initiation management; SIV report review and approval
  • Monitoring Visit Report (MVR) review, management, resolution and escalation.
  • Responsible for timelines, budget and quality of Clinical Monitoring team deliverables, identification of risks and issues and escalation to PM.
  • Coordinate and manage site visit schedules
  • Develop patient recruitment and retention plans
  • Review and approves WTS time reporting.
  • Completing clinical part of Project Review Form and provide information about planned activities to PM to complete the Progression Charts
  • Manages CRA site assignments and schedules.
  • Conducts project co-monitoring, assessment visits and team training.
  • Site contact for protocol clarifications and subject enrolment if CRA unavailable.
  • Protocol deviation documentation, tracking and escalation.
  • Oversees the development of study newsletters communication.
  • Relays project status and issues to PM.
  • Ensures appropriate CRA staffing and resources. Requests additional CRAs/CTAs and removes CRAs/CTAs through planned attrition according to project status.
  • Assists, where appropriate, the PM in discussions with clients on study documentation issues or technical related documentation concerns that may arise.
  • Oversight of CTMS updates
  • Coaches/mentors CRA team.
  • Develops project-specific training materials for team.
  • Ensures project consistency within and across projects by following POI SOPs.
  • Assists and supports in the preparation of study specific training matrix and various training material used by Pharm-Olam. Assists and supports web based training material preparation. Assists when needed in the preparation of company and scientific/medical presentations to potential clients and at Investigators’ meetings and other committees’ meetings as requested.
  • Manages  Investigator and Site Payments
  • May be assigned to monitor 1-2 sites.


Working Relationship:

  • Reports to the Senior Clinical Research Manager, Clinical Operations Manager, Associate Director of Clinical management or designee.
  • Collaborates with Project Management, Clinical Research Managers, QA and other POI departments.
  • Liaises with clients as requested by the PM.


Education Requirements and Qualifications:


  • A degree in life science or nursing qualification (preferred but not required)
  • At least 6 years minimum experience with at least 1 year as a Lead Senior CRA leadership experience.
  • Ability to mentor and train other CRAs in a positive and effective manner.
  • In-depth knowledge of clinical trials and the critical elements for success in clinical trials.
  • Strong therapeutic background.
  • Possesses experience and knowledge in the CRO industry that will support Pharm-Olam’s management of clinical trials.
  • Demonstrates the  ability to successfully manage people/project issues.
  • Mature management skills demonstrated by calm and thorough review of situations.  Proactively identifies and addresses problems.  Seeks to understand all contributing factors.  Proposes, implements, and evaluates appropriate resolutions.
  • Demonstrates the ability to define and meet project requirements.
  • Demonstrates flexibility for improvement and creating solutions.
  • Proven organizational abilities, and excellent written and oral communication skills.
  • Excellent team player with team building skills.
  • Strong customer focus.

**Please note that you must be eligible to live and work in The US in order to apply for this position**


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Apply for this job: Clinical Team Leader (CTL) - US Based

Contact Information:

Address:  Pharm-Olam International
The Brackens, London Road, Ascot, Berkshire
Tel:  +44 (0) 1344 891121
Fax:  +44 (0) 1344 890335
Website:  Visit Our Web Site

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