Senior Manager Project Manager

Description

• Quality and timeliness of study deliverables: site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation and sites closures for assigned study(ies). This includes:
• CDA delivery and negotiation (based on pre-approved parameters and regardless of executory party).
• Conduct of country feasibility assessment of potential studies with the highest quality, in collaboration with other functions such as Medical.
• Ensuring site selection process is conducted by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
• Ensuring timely submission of application/documents to evaluating authorities (i.e: EC/IRB and Competent Authorities as applicable) at start up and for the duration of the study, in line with local regulations. This will include the coordination and collaboration, with the start up positions (where available) of the preparation of the country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translation, in line with relevant SOPs. country/site level for the assigned studies.
• Collaboration for the negotiation of site study contracts and budgets for the assigned studies at country level in coordination with other functions such as start up manager. The SM PMCO will ensure timely preparation of local Master CSA (including site budget) and amendments as applicable in the country.
• Ensuring that all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with applicable SOPs.
• Driving the exercise for site activation projections for the assigned studies
• Set up and maintenance of the study in CTMS at study country level as well as local registries and websites as required by local laws and regulations.
• Oversight, management and coordination of monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
• Meeting recruitment targets for assigned study(ies) and driving the exercise of recruitment projections for the assigned studies.
• Proactive reporting of study-specific issues (including monitoring metrics) to the study team via
• Functional reporting to HCO and LM including:
• Updates about the performance of local study team (CRAs, CSA, etc.)
• Regular information at country level on study/ies and planned study milestones/key issues.
• Leading risk-based quality meetings, project performance reviews, etc for the assigned studies.
• Regular information on any research related information including sites/investigators/competing studies that might be useful for the local market.
• Support in local / global initiatives as agreed with line manager.
• Endorsement by HCO in study activities subject to discussion with HCO (e.g: selection of sites, country commitment for the delivery of the trial, etc)
• Relationship management with the national coordinating investigator as applicable and coordination of country level engagement activities.
• Scheduling and leading effective country calls with local study team and/or CRO, as applicable.
• Leading recruitment discussions with relevant stakeholders (e.g: Medical functions, Patient Advocacy, global study functions) for the assigned trials and countries.

Qualifications

• Proven experience in leading the delivery of operational aspects of all stages of the clinical trial process.
• Solid knowledge of clinical development processes, with previous project/site management experience.
• Ability to lead, troubleshoot and influence for quality and delivery.
• A track record of ensuring GCP compliance and successful risk management of complex clinical studies is expected.
• Proven experience in effectively communicating with site staff including KOLs and thought leaders.
• Comprehensive and current regulatory knowledge, including GCP.
• Experience conducting GCP or other training is a plus.
• Flexibility in schedule and willingness to travel (required travel may be as high as 20% during busy periods).
• Good organizational skills and ability to deal with competing priorities.
• Effective communication skills (written, verbal and presentation).
• Creative thinker, curious and unafraid to ask questions.
• Innovator, willing to initiate changes, introduce new ideas, and creatively problem solve.
• Good analytical skills and ability in handling crisis situations.
• Excellent attention to details.
• Proficient with MS Office Suite (Excel, Word and PowerPoint).
• Excellent knowledge of spoken and written English.
• Good intercultural awareness.