Passage Bio is an exciting, fast-paced gene therapy company headquartered in Philadelphia, PA. Our portfolio of rare monogenic CNS gene therapies is the result of an exclusive collaboration with the renowned Gene Therapy Program (GTP) at the University of Pennsylvania (Penn) that provided Passage Bio with 17 gene therapy candidates developed in the lab of gene therapy pioneer Dr. James Wilson. Passage Bio is on a mission to provide life-transforming gene therapies for patients with rare monogenic CNS diseases that replace their suffering with boundless possibility, all while building lasting relationships with the communities we serve.
 
The Role:     
We are seeking a responsible, organized, and highly motivated individual as the Manager of Clinical Operations. This position provides the opportunity to work in our large-scale and fast-paced practice. This is a hybrid position. 

Here Is What You Will Be Doing:

 

·        Responsible for operational study tracking, execution, and management of study delivery.

·        Oversee daily clinical operations aspects for the program to ensure that patients receive quality care in an efficient and customer-centric manner that is in alignment with established policies, procedures, and protocols.

·        Ensure compliance with ICH/GCP guidelines, applicable laws and regulations and SOPs, for their designated studies

·        Partner with the program Director to track all clinical trial related activities

·        Manage feasibility and determine study allocation.

·        Assist with the development of recruitment plan, manages risk, monitors progress, and implements contingencies as required.

·        Support vendor selection and oversight

·        Oversee external consultants including contract research organizations (CROs) and Clinical Research Associates/Assistants.

·        Ensure adequate and accurate electronic medical record documentation through adherence to established ICH/GCP guidelines and SOPs

·        Partner with the program Director to manage the operating budget for the program

·        Ensure appropriate clinical trial supply strategy is implemented and managed.

·        Facilitate the implementation of operational practices that are effective, improve the clinical care, improve the patient experience and ensure quality.

·        Work closely with members of Study Teams to support clinical, quality, regulatory compliance, information systems, fiscal, and research goals and initiatives of the program(s).

·        Work with counterparts in Data Management to establish timelines for data deliverables; responsible for data review as part of the trial team to ensure consistency and accuracy in prep for analysis

·        Review and oversight of metrics reports for Source Documents Verification (SDV) and query resolution

 

Here Is What You Will Bring To The Table:

 

·        Bachelor’s degree (B.A/B.S.) in related field or equivalent preferred.

·        5 plus years related experience or equivalent.  Early phase clinical trial experience preferred. 

·        Practical experience with site management and clinical monitoring

·        Excellent written and oral communication skills

·        Strong organizational, problem-solving, and analytical skills

·        Ability to manage priorities and workflow

·        Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm

·        Ability to work independently and as a member of various teams and committees

·        Proficient on excel, word, power point and practice management software

·        Proven ability to handle multiple projects and meet deadlines

·        Strong interpersonal skills.

·        Ability to deal effectively with a diversity of individuals at all organizational levels.

·        Good judgement with the ability to make timely and sound decisions

·        Ability to understand any and all safety requirements.

·        Ability to effectively communicate with people at all levels and from various backgrounds

Here’s What We’ll Bring To The Table:

·        Up to $270 for public transportation and parking.

·        Highly competitive healthcare coverage including medical offered (HMO/PPO), dental, and vision offered.

·        Flexible Spending Accounts for medical expenses and dependent care expenses.

·        12 weeks of 100% paid parental leave for all new parents within 6 month.

·        401k (traditional and Roth offered) with 5% match.

·        A suite of Passage Bio paid insurance coverage, including life insurance, short-term and long-term disability.

·        Voluntary legal assistance as well as pet, liability, critical illness, hospital indemnity, and accident assistance.

·        20 days’ vacation and Unlimited sick time per year, and 14 company paid holidays (includes 2 floating holidays in addition to a discretionary winter shut down).

Must have received or be willing to receive the COVID-19 vaccination by date of hire to be considered. Proof of vaccination required.

Passage Bio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Passage Bio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.