Clinical Project Manager
Boston, Massachusetts, United States
Posted on: 3/13/2017
Job type: Permanent
Sector: Pharmaceutical and Healthcare
TiGenix S.A.U/Clinical Development
Job title : Clinical Project Manager US
Reports to : Clinical Development Director
Purpose of the job: Plan, budget, coordinate and execute allocated TiGenix clinical trials and assist with training and development of clinical monitoring task. Primary contact with CRO PM
* Oversee all the clinical trial activities by project
* Develop and track a project plan (with timelines and objectives), under coordination of the Clinical Development Director. Contribute to trial specific document development. Contribute to site and CRO selection. Assist project team with site initiation visits. Ensure that the data documentation and insurance requirements are met. Control the site contracts fully execution.
* Manage project deliverables, improving patient recruitment, ensuring compliance to regulatory requirements, assuring that objectives are met within approved budget and timelines. Enhance efficiency of clinical projects. Report to the Clinical Development Director with regard to quality, milestones, timelines and budgets.
* Provide leadership in assuring the integrity of clinical data with respect to accuracy, accountability, documentation and methods or procedures through review of case report forms. Recognize, detect and prevent fraud and misconduct. Implement corrective actions when appropriate.
* Assist Clinical Development Director in planning and organizing all project key milestones e.i Investigators meeting, Safety Plan, BDRM, SAP, etc…
* Develop and track a project budget under supervision of the Clinical Development Director: predicting costs and developing time-phased budgets to create faster turnarounds at lower costs. This will include the identification and management of internal and external partners, contract management, negotiation and track payments (Clinical research sites, CRO and outside consultant).
* Lead study team in house (when applicable). Coordinate and steer the activities of all team members including CTO and CTAs
* Manage as primary contact the CRO PM. Validate the appropriate skills of the outsourced clinical trial team for the conduct of the study. Conduct their study specific training and development activities including on-site coach for CRA's.
* Co-Chair project TC with CRO and review of minutes. Review of monitoring visits reports in-house and outsourced
* Assist in the review of Audits and preparation of the answers of the CAPA plan
* Lead IMP needs and supervise CTO or designee , IMP shipment activities. Contact with logistics vendors when needed.
* Assist with the development of departmental SOPs, WI and study specific procedures. Fulfill all responsibilities in accordance with TiGenix SOPs and compliance policies as well as according to ICH GCP and applicable regulatory guidelines and legislation.
Skills, experiences and qualifications required for the job:
- Excellent knowledge of clinical drug development process
- Knowledge of global clinical trials regulations and guidelines (GCP & GPV guidelines, EMEA, FDA regulations, ICH guidelines, local laws, etc.).
- Effective written and verbal communication skills in English and Spanish.
- Collaborates effectively with the project leaders/ lead CRAs, members of the study team, cross-functional team members and external partners.
- Proficiency in the use of email, word processing, excel. Will develop project management software skills.
- Excellent team management and leadership skills
- Excellent interpersonal and organizational skills
- Good negotiation and communication skills, problem solving techniques
- University degree - scientific, medical or paramedical equivalent.
- Minimum three (junior)/five (senior) to ten years experience in clinical research (Pharma Company or CRO).
- Experience in clinical development from Phase I to Phase III
- Project management skills