Contract Clinical Program Manager | BioNJ Talent Services

Contract Clinical Program Manager

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

PTC is a science-led, global biopharmaceutical company focused on the discovery, development and commercialization of clinically-differentiated medicines that provide benefits to patients with rare disorders. Founded over 20 years ago, PTC Therapeutics successfully markets rare disorder products and has a robust pipeline of transformative medicines. When you combine great causes with great people, you find a culture that thrives on collaboration and creativity. PTC is a committed group of people that have a passion for science and a strong desire to succeed in an environment that is rewarding, inclusive and respectful. Join us on our journey as you grow your career.

Job Description:

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

Primary duties/responsibilities:

*Contributes to the development and or review of clinical study related documents (e.g 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 documents as required.

*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;; ensures essential 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.

*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.

Qualifications: 

Minimum level of education and years of relevant work experience.

Bachelor’s degree in a scientific discipline and a minimum of 4 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.

*Previous experience as a field monitor.

*Medical writing experience or training.

Additional Job or Internship Information
Position Type: 
Contract
Function: 
Clinical Operations