Clinical Team Manager - Spanish language & LATAM experience required

Ergomed • Raleigh, NC

4h • Remote

About The Position

Ergomed is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.
Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia
Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development.
We have nourished a true international culture here at Ergomed.
We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Come and join us in this exciting journey to make a positive impact in patient’s lives.
Oversees and supports country level feasibility, Investigator identification and selection, if applicable.
Oversees and supports the contracting process with investigational sites (e.g.investigator / team, institution as applicable) or local vendors
Responsible for overall management of project allocated direct reports (CRAs, Site Managers and CTAs, as applicable)
Organizes and facilitates internal project team meetings (e.g. weekly calls with CRAs, Site Managers, CTAs) and ensures meeting minutes are reviewed, approved and distributed to all concerned parties
Develops, reviews and revises project documents (e.g. Clinical Monitoring Plan, CRF completion guidelines, study specific operating manual, study specific forms etc.).
Prepares the Site Management Plan for a particular study, if Lead Site Manager is not assigned.
Supports PM in development of study related share point in order to facilitate sharing of key study documents / guidelines / templates, and reporting / review of study status reports and Key Performance Indicators (KPIs)
Initiates corrective / preventative measures – e.g. update of study guidance documents, performing re-training, performing quality assessment visits etc.
Supports PM in execution of KPIs for the assigned staff and for all sites’ deliverables within required time and budget (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
Reviews and verifies that all required documents are in good order for the first Investigational Medicinal Product (drug) release to the investigational site, if task assigned in the specific project
Supports PM in setting up and maintenance of the clinical trial master files (TMF) as per Ergomed /Sponsor SOPs and study specific Filing 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
Reports all site issues (unable to resolve on CTM level) to PM/designee with action plan / propositions for discussion
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
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
Coordinates and ensures the adequate preparations for site specific audits and inspections, attends in-house project audits if required, analyses the received audit report / findings, proposes and oversees creation and completion of Corrective and Preventative Action Plan

Requirements

• Extensive clinical research lead experience in multiple studies
• Experience in managing Clinical part of studies in more than one region or equivalent study complexities
• Experience of phase 2/3 trials, ideally complex studies such as oncology or rare disease
• Able to work in a fast-paced small CRO environment and manage multiple projects
• Spanish language skillls and experience in LATAM
• A minimum of a science-based bachelor’s degree
• Able to work effectively with minimal supervision

Responsibilities

• Oversees and supports country level feasibility, Investigator identification and selection, if applicable.
• Oversees and supports the contracting process with investigational sites (e.g.investigator / team, institution as applicable) or local vendors
• Responsible for overall management of project allocated direct reports (CRAs, Site Managers and CTAs, as applicable)
• Organizes and facilitates internal project team meetings (e.g. weekly calls with CRAs, Site Managers, CTAs) and ensures meeting minutes are reviewed, approved and distributed to all concerned parties
• Develops, reviews and revises project documents (e.g. Clinical Monitoring Plan, CRF completion guidelines, study specific operating manual, study specific forms etc.).
• Prepares the Site Management Plan for a particular study, if Lead Site Manager is not assigned.
• Supports PM in development of study related share point in order to facilitate sharing of key study documents / guidelines / templates, and reporting / review of study status reports and Key Performance Indicators (KPIs)
• Initiates corrective / preventative measures – e.g. update of study guidance documents, performing re-training, performing quality assessment visits etc.
• Supports PM in execution of KPIs for the assigned staff and for all sites’ deliverables within required time and budget (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
• Reviews and verifies that all required documents are in good order for the first Investigational Medicinal Product (drug) release to the investigational site, if task assigned in the specific project
• Supports PM in setting up and maintenance of the clinical trial master files (TMF) as per Ergomed /Sponsor SOPs and study specific Filing 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
• Reports all site issues (unable to resolve on CTM level) to PM/designee with action plan / propositions for discussion
• 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
• 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
• Coordinates and ensures the adequate preparations for site specific audits and inspections, attends in-house project audits if required, analyses the received audit report / findings, proposes and oversees creation and completion of Corrective and Preventative Action Plan

Benefits

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level