Clinical Team Manager

Job Description

The Clinical Team Manager (CTM) is a Functional Lead for Clinical Operations; CTM is responsible for operational management for assigned countries and sites and coordinates and oversees the activities of allocated CRAs.
The CTM is responsible for developing study Clinical Monitoring Plan (CMP) and monitoring of both resource
allocation and clinical trial so that all aspects of the CMP are in progress. The CTM proactively identifies, resolves
/ mitigates and escalates risks and/or issues to the PM, PD, CTM Line Manager and Clinical Operations leadership.

ROLE AND RESPONSIBILITIES

• Responsible for overall management of project allocated clinical team (e.g. CRAs)
• Develops, reviews and revises project documents (e.g. Clinical Monitoring Plan, Site Management Plan if Lead Site Manager not assigned, study specific annotated site visit report templates, CRF completion guidelines and performs UAT, study specific operating manual, study specific forms etc.)
• Supports PM in execution/oversight of study KPIs for the assigned staff and sites’ deliverables within required time and budget (site activations targets met, site recruitment targets met, query resolution, source data verification, timely issue resolution); supports a proper flow of processes in the projects in cooperation with other departments, if needed; supports PM in client invoicing confirming units/tasks completed for Clinical Operations; approves project related time spent for assigned staff
• Provides Clinical Operations contribution to Risk Management – identification, evaluation, control, communication, review and reporting, including Clinical Operations contribution to discussions/proposals for Critical to Quality Factors & Quality Tolerance Limits.
• Provides recommendation to PM and the Sponsor about selection of investigators and sites if contracted to Ergomed; PSV report review and approval.
• Oversees site initiations including initial supply management
• Reviews and verifies that all required documents are in good order for site activation
• Coordinates and manages CRA site assignments and site visit schedules
• Organizes and facilitates internal project team meetings (e.g. regular calls with CRAs) and provides study status or protocol deviations/non-compliances status at external meetings
• •Supports PM in setting up and maintenance of the clinical trial master files (TMF) as per Ergomed /Sponsor SOPs and study specific Fling Plan, is accountable for the ongoing and final QC of the assigned sections of TMF and ensures study file reconciliation of the clinical part of the TMF (country and site files) towards the end of the trial and before transfer to the Sponsor
• Reviews site visit reports created by CRAs and ensures they are finalized within expected timeline and in good quality
• Monitor and manage trial materials supplies. Ensures Investigational Product and other study supplies are available at sites
• Reviews data listings and query reports to identify trends and ensures proactive mitigation actions implementation and/or re-training is conducted with CRAs and site staff
• Oversees the process of protocol deviation documentation, tracking and escalation; Reviews the cumulative listings of study non-compliances (project related deviations / issues) and assesses whether there are any trends at the site or on a study level and assesses whether any additional corrective / preventative actions should be taken and communicate this to the responsible parties
• Acts as site contact for when CRA is unavailable
• Reports all site issues (unable to resolve on CRA/CTM level) to PM/designee with action plan / propositions for discussion
• Oversees and verifies executions of tasks assigned to clinical staff in the scope of assigned study (e.g. including provision of approval for CRA travel arrangements)
• Manages successful trial close-out, identifies critical activities to make timely and efficient close-out
• Direct communication and collaboration with the Sponsor representative in projects as required.
• Informs PM/PD of any problems arising during the cooperation with investigators, Sponsors or partners and escalates to PM/PD, LM or Head of Department immediately about all quality, safety or legal issues
• Participates in the development of study newsletters if applicable
• Collaborates cross-functionally to develop patient recruitment and retention plans
• Coordinates and ensures the adequate preparations for site specific audits and inspections, attends inhouse project audits if required, analyses the received audit report / findings, supports the investigation of root causes, proposes and oversees creation and completion of Corrective and Preventative Action Plan
• Initiates corrective / preventative measures – e.g. update of study guidance documents, performing retraining, etc.
• Participates in mentoring/training of new staff as well as performs Monitoring Evaluation Visits to assess CRA performance
• Oversees and supports the contracting process or invoicing of local vendors completing clinical activities
• Develops, reviews, and revises Ergomed SOPs within area of expertise in order to ensure consistency with Good Clinical Practices and other applicable regulatory standards / requirements
• Actively participates in preparation, attendance and presentation of bid defense meetings
• Participates in company process improvement initiatives
• As necessary, performs monitoring activities based on project needs

Qualifications

• Degree or RN degree in a life science or other related field, orequivalent education and experience.

• A minimum of 6 years clinical research experience in multiple studies and countries.

• Experience in managing Clinical part of studies in more than one region or equivalent study complexities

• Ability to mentor and train other CTMs and CRAs in a positiveand effective manner.

• In-depth knowledge of clinical trials and the critical elements for success in clinical trials.

• Diverse therapeutic area expertise and skills

Additional Information

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.  

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here. 

• Quality: we hold ourselves to the standard patients deserve. 

• Integrity and trust: we do the right thing, especially when it is hard. 

• Drive and passion: we care about the outcome, because someone is waiting on it. 

• Agility and responsiveness: we move quickly, because patients cannot wait. 

• Belonging: everyone is welcome, and every voice counts. 

• Collaborative partnerships: we go further by going together. 

We look forward to welcoming your application.