Senior Clinical Trial Manager

Primary Responsibilities

Senior Clinical Trial Manager is responsible for ensuring the quality of clinical trials and implementing and overseeing various projects. Senior Clinical Trial Manager collaborates with the designated CRO and vendors, as well as internal team across functions, and directs activities to execute and deliver the assigned studies.

This role reports to the Director of Clinical Operations.

Specific Duties , may include but not be limited to the following:

* Acting as a primary liaison with the CRO/CROs on the assigned projects, including global multi-center trials.

* Providing management and oversight for the CROs/vendors involved in the assigned projects ensuring on time and on budget delivery.

* Partnering with other functions internally to achieve key milestones, optimize processes and achieve efficiencies.

* Providing regular reporting on project metrics and serving as internal liaison at Immuneering, regarding all project related inquiries, presentations and updates

* Creating and implementing study-specific clinical monitoring tools and documents in collaboration with CRO/vendors and internal team.

* Identifying and choosing/approving sites and coordinating site startup activities.

* Supervising and having regular meetings with the CRO and other clinical vendors involved in the projects

* Reviewing the clinical trial agreements and budgets for the CRO, vendors and clinical sites

* Overseeing the CRO's contact with the study sites, including ordering/providing supplies and investigational product, and site management.

* Ensuring inspection readiness and that all study activities are conducted in compliance with the protocol and procedures, GCP, FDA/EMA/local regulations, guidelines and policies.

* Escalating issues as needed to the Sr Director, Clinical Operations with the proposed action plan

* Participating in the development of SOPs, working guidelines, mentoring and educational activities

* Managing task with minimal to no supervision

Qualifications

EDUCATION

* B.S. (or higher) degree in a Science or related field required

* Minimum 8 years of work experience for a pharmaceutical company or CRO

* Minimum of 8 years of work experience in PM/CTM (or equivalent) roles on Oncology projects

* Global multi-center trial experience is required

* Demonstrated application and working knowledge of global GxP regulations for pharmaceutical industry (i.e., Good Clinical Practices, Good Lab Practices, current Good Manufacturing Practices, 21 CFR Part 11 Electronic Records; Electronic Signatures, MHRA/EMA/FDA regulatory body inspections)

TECHNICAL / SOFT SKILLS

* Outstanding communication skills, both verbal and written

* Proficient with Microsoft Office Word, Excel, PowerPoint, MS Project

* Ability to work independently and prioritize duties

* Understanding of Electronic Data Capture (EDC) and other clinical systems

* Strong analytical and organization skills

* Self-motivated and self-directed

Physical Demands/ Working Conditions

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.

Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role.

While extensive travel is not anticipated with this role, it is possible to perhaps up to 10% uires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role.

Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs.

We encourage individuals from all backgrounds to apply and join us in our mission.

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