Passage Bio is an exciting, fast-paced gene therapy company headquartered in Philadelphia, PA. Our portfolio of 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 CNS diseases that replace their suffering with boundless possibility, all while building lasting relationships with the communities we serve.

 

The Role:  

   

Passage Bio is currently seeking a Associate Director of Data Management to join their team. The role will be challenging but also highly rewarding and this leader will be a key voice in the company. For the right executive, this is a fantastic opportunity with great growth prospects.

 

Here is what you will be doing: 

  • Interconnect with clinical counterparts for project data cleaning and resolution of issues
  • Lead data management studyp and maintenance activities
  • Prepare data management plans and essential documentation
  • Review clinical data and implement and escalate solutions, as appropriate
  • Lead database lock activities
  • Work with Clinical and Biostatistics personnel and CROs to design and develop study documents
  • Manage CROs to ensure that outsourced data management tasks remain on target according to projects' timelines and budgets
  • Manage third-party vendors
  • Perform data reviews and generate queries and resolutions
  • Plan and perform UAT of clinical database
  • Lead cross-functional discussions to define data handling and design standards
  • Define projects’ timelines and deliverables and work closely with cross-functional teams
  • Ensure that functional deliverables are completed on-time and budget and according to the highest quality, ethical and professional standards
  • Work closely with key strategic alliance partners for projects that are being jointly developed
  • Identify project risks with inputs from cross-functional teams and support in resolving issues
  • Prepare and oversee monthly progress and ad-hoc reports, as required
  • Support Standard Operating Process creation, process improvement and functional trainings at departmental and company level
  • Ensure compliance with corporate policies, procedures and healthcare-related laws and regulations

 

Here is what you will be bringing to the table: 

 

  • BS degree is required.
  • Appropriate full-time work experience is mandatory
  • Recent experience in the biotechnology industry is strongly preferred 


Here's what we will 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.


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