Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms RSS Feed RSS Feeds RSS Feed PharmiWeb Candidate Blog RSS Feed PharmiWeb Client Blog

Job Details

Clinical Team Leader (CTL) - Sofia, Bulgaria

Company: Pharm-Olam International
Location: Sofia, Bulgaria
Reference: CTL/BUL
Closing Date: 17 Nov 16
Type: Full Time
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: Office Based - Sofia, Bulgaria

Job Type: Permanent


Key Responsibilities:

  • Manage the study start up in collaboration with PM and Regulatory Lead
  • Coordination and oversight of Critical documentation
  • Preparing Monitoring Plan
  • Modifying visit reports according to 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 escalating 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 enrollment 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.
  • 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.
  • Assists and supports in the preparation of study specific training matrix and various training material used by Pharm-Olam
  • Manages Investigator and Site Payments
  • May provide line management to CRAs (Europe).
  • 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 Pharm-Olam departments.
  • Liaise 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 with 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.

Apply for this job: Clinical Team Leader (CTL) - Sofia, Bulgaria

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

Share | | |
Site Map | Privacy & Security | Cookies | Terms and Conditions is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.