Sr Clinical Program Manager - Contract | BioNJ Talent Services

Sr Clinical Program Manager - Contract

Contact Information
Contact Name: 
PTC Therapeutics
Organization Name: 
PTC Therapeutics
Position Location: 
South Plainfield
Company Profile: 

Translating Science. Transforming Lives.

Our mission at PTC Therapeutics has always been to build an integrated biopharmaceutical company based on our expertise in RNA biology. We have focused on discovering and developing novel oral treatments for patients with serious and life-limiting disorders. By targeting the processes that modulate RNA biology and affect protein production, we bring an innovative approach to drug discovery. We are focused particularly on the development and commercialization of treatments for rare and neglected disorders.

Commitment to Patients.

We are committed to finding treatment options for patients living with life-threatening diseases. Our lead product candidate is ataluren for the treatment of patients with genetic disorders due to a nonsense mutation. Ataluren is in clinical development for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). Ataluren has been approved under the trade name Translarna™ in the European Union for ambulatory patients with nmDMD who are 5 years and older.

Job Description:

The Senior Clinical Program Manager provides the scientific and operational expertise required to conduct clinical trials in accordance with appropriate regulatory requirements for one or more indications within or across therapeutic areas. This includes, but is not limited to: working as an integrated member of the clinical team to develop, implement, and manage clinical trial(s) from study design through close out; establishing/managing relationships with assigned investigator sites, vendors and consultants to ensure timelines and deliverables are met and that studies are conducted in accordance with appropriate regulatory requirements. The incumbent also reviews, and contributes to, if needed, the development of clinical study-related documents.

The incumbent works cross-functionally with internal departments and external resources on Clinical Research related issues.

The Senior Clinical Program Manager supports adherence to relevant regulatory requirements and company Standard Operating Procedures {SOPs) as appropriate.

This a long-term contract assignment, with potential for renewal.

Primary duties/responsibilities:

*Participates in the research, writing and finalization of clinical study-related documents such as protocols, protocol amendments, study manuals, Informed Consent Forms {ICFs), Case Report Forms (CRFs), Investigator's Brochures {IBs), Clinical Study Reports {CSRs), regulatory submissions and other publications as required.
*Searches and reviews literature sources and summarizes and presents findings.
*Establishes and maintains relationships with assigned investigator sites, vendors and consultants.
*Prepares potential investigator site lists and assists with their evaluation for inclusion in the study; participates in negotiations and maintains investigator study budgets and assists with Clinical Trial Agreements as necessary; ensures e·ssential clinical documents are in place for assigned sites to ensure timely site initiation and patient enrollment.
*Ensures investigator and investigator site personnel comply with protocols; recommends corrective action(s) as required.
*Assists in the oversight of the shipment of and return of clinical supplies (drug and non-drug) for assigned sites, as necessary
*Performs periodic review of clinical data to ensure the data is accurate and complete.
*Summarizes results from clinical studies for submission to global regulatory agencies.
*Maintains accurate and updated study files.
*Assists in the design and implementation of standardized work processes.
*Participates in the selection and oversight of external service providers, including CROs and other vendors as necessary. *Contributes to, and participates in, budget development, contract negotiations and expenditure oversight
*Prepares investigator site lists for study feasibility and participates in their review and approval for inclusion in the study. Plans, coordinates and participates in investigator meetings including developing and presenting assigned sections of the meeting agenda/content.
*Recommends strategies for, and oversees, the execution of activities associated with clinical monitoring, safety, eligibility, enrollment, and data consistency. Assists in configuration and implementation of study-related systems as appropriate (i.e. data management, study drug tracking, etc.).
*Performs other tasks and assignments as needed and specified by management.



Bachelor's degree in a scientific discipline and a minimum of 6 years of experience in clinical research working in a pharmaceutical, biotechnology, Contract Research Organization (CRO) or related environment.

Special knowledge or skills needed and/or licenses or certificates required.

*In-depth understanding of the drug development process.
*Working knowledge of, and experience with, clinical trial design, conduct, data acquisition and reporting.
*Working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
*Proficiency with Microsoft Office.
*Excellent verbal and written communication and skills.
*Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
*Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.
*Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Special knowledge or skills and/or licenses or certificates preferred.

*Prior involvement in lnvestigational New Drug applications (INDs) and New Drug Applications (NDAs) submissions.
*Previous experience as a field monitor.
*Medical writing experience or training.
*Experience with Microsoft Project.

Essential Functions

PTC Therapeutics, Inc. (“PTC”) is an equal opportunity employer. PTC considers all applicants for employment without regard to race, creed, color, religion, age, sex (including pregnancy), marital/family status, domestic partnership or civil union status, affectional or sexual orientation, gender identity or expression, atypical hereditary cellular or blood trait, genetic information, national origin, nationality, ancestry, disability (and perceived disability), military service or any other status protected by law. It is also PTC’s policy to prohibit discrimination, including harassment, against any applicant or employee based on any of these protected categories.

Additional Job or Internship Information
Position Type: 
Project Management