Trial Associate, Global Medical Affairs Study Management, Japan (TEMPORARY)Location Tokyo, Japan
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
BioMarin Global Medical Affairs (GMAF) offers scientific and clinical expertise to post-marketing products through the direction and planning of medical communications, support of education and research, liaising with the medical community, response to incoming inquiries about Medical Affairs products and trials, and leadership of the execution of Medical Affairs trials.
Within BioMarin GMAF, the Study Management (SM) group is responsible for managing the strategy and execution behind BioMarin’s studies, ensuring efficient, comprehensive, and compliant data collection to support BioMarin products.
The Trial Specialist is an essential role focused on executing and overseeing site conduct activities for GMAF SM sponsored clinical and post marketing surveillance trials, including site start-up, maintenance and close-out activities, co-monitoring, and vendor management. At this stage, the Trial Specialist is responsible for assigned trial(s), including both clinical and post marketing surveillance, under the guidance of more senior team members.
The individual in this role is developing the core competencies of leadership, strategic thinking and planning, problem solving, and decision making. S/he is developing technical knowledge related to drug development and therapeutic area knowledge while exhibiting foundational skills in compliance, clinical trial, post marketing surveillance programs, and project management.
Responsibilities may include, but are not limited to:
Contracts and Vendor Management
- Manage site budget and contract negotiation, payment, and processing activities in collaboration with the Study Manager, Legal, and Finance
- Participate in the selection of vendors and support Study Manager in oversight of vendors across assigned trial(s); may include contract negotiation, change orders, budgeting, and meeting facilitation
- Support development of materials for submission to regulators in collaboration with cross-functional partners
- Support BioMarin Pharmacovigilance with obtaining information for safety reporting from sites according to BioMarin Pharmacovigilance processes and country specific regulations
- Support the Study Manager with the planning of advisory board meetings with investigators in collaboration with the medical director to provide updates on the PMS program
- Support the Study Manager in auditing study files to ensure they are ready for regulatory inspection
- Support the Data Manager/vendor/Study Manager with the review of survey information, case report form data and entry into the appropriate databases
- Collaborate with medical science liaisons (MSLs) and/or regional medical directors to support sites as appropriate
- Responsible for development of site enrollment plans, start up materials, informed consent document templates (ICD), and other trial related plans (e.g. monitoring plan)
- Participate in the preparation and finalization of protocols, clinical study reports, and interim reports
- Responsible for the final review of the site level documentation and approval for initiation
- Liaise with supply chain for investigational product forecasting at the site level, including shipment and reconciliation activities
- Responsible for ensuring all supplies required for trial participation by sites are available
- Responsible for implementation of site feasibility, selection, activation, training, maintenance and close-out activities
- Responsible for implementation of trial plans for site oversight according to the monitoring plan
- Communicate with field CRAs and site staff for timely data collection and query resolution
- Oversee site documentation activities (TMF reconciliation, filing, and archiving)
- Responsible for adherence to timelines and quality at a site level for assigned trial(s)
- Partner with Data Management to coordinate and participate in data reviews and ensure data collection and query resolution occur in a timely manner
- Collaborate with Pharmacovigilance and Medical Monitor on reconciliation of safety data
- Identify and anticipate problems at a site level in collaboration with Field CRAs throughout the life of the trial (i.e., reviewing potential corrective and preventative actions with Study Manager, and implementing agreed upon solutions)
- Identify potential protocol deviations and escalate per protocol deviation plan
- Responsible for corrective and preventative actions resulting from a site audit
- May support junior staff assigned to trials
- A Trial Specialist demonstrates foundational core competencies across leadership, strategic thinking, and problem solving. This includes (but is not limited to):
- Demonstrating an understanding of departmental objectives and how they support corporate strategy
- Setting short-term and longer-term goals for individual objectives and task completion, while also identifying short and long-term opportunities and risks
- Demonstrating an ability to recognize, understand, articulate and respond promptly to issues, risks and opportunities that arise
- Demonstrating understanding of existing process, SOPs, work instructions (WI) that affect current work
- Demonstrating knowledge of site and trial management practices, including site evaluation, site staff training, patient recruitment, site initiation, co-monitoring, sample management, and close out
- BA/BS or higher in life or health sciences preferred. Industry or relevant experience in lieu of education accepted
- 2 years of relevant experience in clinical science, clinical trial or site management, medical affairs, and/or drug development
- Proficient in spoken and written English
- The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 20 lbs. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
- External: Clinical Trial Site Staff, vendors and suppliers
- Internal: Clinical Operations, Medical Communications, Regulatory Affairs, Patient Advocacy, Medical Directors and Medical Science Liaisons, Medical Information, Legal, Corporate Ethics & Compliance, Pharmacovigilance, Biometrics, Development Sciences Quality (DSQ)
- Computer work utilizing common business software programs and hardware solutions.