Clinical Project Manager at Corcym

POSITION SUMMARY:

Under limited supervision, assists the Clinical Affairs Manager with the management of the clinical studies in accordance with the applicable domestic and international government regulations, Clinical Investigation Plans, and Standard Operating Procedures. Assist with the development of effective clinical trial strategies, preliminary project timelines, and budgets for clinical project(s) to ensure successful product development and worldwide marketing efforts.

The Clinical Project Manager main activities are assisting with the study design, coordinating, managing and working with clinical support resources such as a clinical research monitors/clinical research associates, Field Clinical Managers, and CROs. Provide clinical support to Sales and Marketing Departments as required.

Work closely with the Clinical Affairs Manager to recommend and implement improved methods by developing and/or modifying department procedures, systems, and in-house training that ensure compliance with regulatory requirements.

ESSENTIAL JOB FUNCTIONS:

Essential Job Functions include, without being limited to:

Clinical Management Responsibilities:

• Coordinate project team meetings;

• Assist Clinical Affairs Manager with the development of clinical study strategies;

• Provide input to the study design and protocol development;

• Prepare, review, and distribute study plans, study agreements, informed consent forms, and other study materials;

• Assist with and coordinate preparation of regulatory applications, amendments, questions from the authorities, supplements, reports, and advisory panel presentations needed to conduct studies and approve products;

• Assist and drive clinical site selection;

• Establish and maintain first-line contact with investigators and site staff;

• Oversee and provide clinical input for the design of the Case Report Forms and electronic databases;

• Prepare and give clinical presentations to physicians, clinical study staff, agents and distributors, as required;

• Review and verifies adequacy of site activation documentation;

• Assure clinical studies are adequately managed to meet the protocol objectives and schedules;

• If applicable, support Data Monitoring Committees (also called Data Safety Monitoring Boards) and other committees/consultants established to support the studies;

• Assist data management staff with clinical data review and collection of data from sites;

• Assists and oversees study compliance/safety including data integrity: protocol deviations, adverse events, issues etc. If applicable, collaborates with the data manager to implement risk-based study management;

• Help to ensure sponsor and site compliance to domestic and international government regulations;

• Communicate regarding the study internally and with participating sites on issues, questions, and study updates;

• Assist with clinical study site monitoring, as necessary and review of monitoring activity/reports;

• Take initiative to oversee activities of Contract Research Organizations (CRO's), if applicable;

• Create, update, and maintain site administrative files and trial master files (electronic and/or paper);

• Maintain accurate and up-to date study tracking documents (eg enrollment, regulatory approvals and renewals, payments) and systems;

• For premarket studies, instruct warehouse and field staff in clinical device distribution and recovery. Maintain device accountability report;

• Coordinate and assist data manager and biostatistician with the data review, analysis and preparation of the study reports and coordinates their deliveries;

• Preparation of study data publication and presentation, coordinating with data manager and biostatistician, Clinical Affairs Manager and Medical Affairs;

• Coordinate closeout of sites/study, archive study documents.

Project Management:

• Manage the delivery of study requirements to the protocol, the site needs and the required timelines set for the project;

• Apply principles, concepts, and techniques for effective project management of a clinical study;

• Establish priorities among activities;

• Track and measure project variances;

• Provide input for clinical study budget and project plans;

• Seek input from higher-level clinical experts or program management as issues warrant;

• Work with Clinical Affairs Manager to recommend and implement methods for improving processes and addressing issues within the clinical research department;

• Understand and take lead in explaining issues and defining possible responses/ solutions/ alternative approaches.

KNOWLEDGE, SKILLS AND ABILITIES:

• Autonomous in utilization of MS Office software package (Word, Excel, PowerPoint, Outlook);

• Knowledge of clinical data management systems, and processes; and electronic data capture systems (EDC);

• Good presentation skills;

• Ability to work with cross-functional teams;

• Strong interpersonal solution-oriented skills;

• Organized and ability to work with limited supervision;

• Ability to work in a fast-paced environment and managing priorities with attention to detail, timelines, and project objectives;

• Product development and Product Marketing understanding;

• Thorough knowledge of international regulations and guidelines (ISO 14155, GCP, GDPR, FDA) and internal standard operating procedures;

• Fluency in English, additional languages is a plus;

• Good verbal and written communication skills;

• Available to travel if needed.

EXPERIENCE:

A minimum of 2-3 years’ experience in clinical research, including managing international clinical trials in the Medical Device, Pharmaceutical or CRO environment (Medical Device is strongly preferred);

• CRA background and monitoring experience;

• Experience drafting, editing and reviewing technical documents such as clinical protocols, study reports, study trial manuals, CRFs, etc…;

EDUCATION:

• Bachelor’s degree or higher degree in the medical, biological and/or bio-engineering field, or RN;