Contract, Biostats Operations Group Coordinator

Job Description Summary:

The Contract, Biostats Operation Group (BOG) Coordinator performs system and process support activities for the PTC Biostatistics and Data Management (BioMetric’s) Department. This includes, but not limited to, proactively and independently identifying, coordinating, and monitoring the administrative aspects of the BOG support function; performing ad-hoc and project-driven administrative tasks as assigned, including administrative systems, processes and procedures and completing of varied routine activities.
The incumbent works cross-functionally with internal departments and external resources on computerized systems, processes, and related support issues.
Quick paced position in rapidly expanding environment.
The Contract, Biostats Operation Group (BOG) Coordinator supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

The BOG Coordinator's responsibilities include, but may not be limited to:

• Assisting with the initiation, completion, management, and archiving of legal and financial documents for the clinical programs, such as non-disclosure agreements, new vendor requests, vendor contracts, invoices and purchase orders.

• Providing general administrative support to the BOG function that supports the study teams including:

  • Overseeing the monthly invoicing process.

  • Reviewing accruals with teams.

  • Ensuring contracts/work orders/amendments are created and approved in a timely manner.

  • Collaborating with other departments.

  • Format documents.

  • Assist in signature collection.

  • Managing department electronic mailboxes and other resources.

  • Oversee the BOG Request system that tickets are assigned and resolved in a timely manner.

  • Oversee processes to revise data for decision making tools within and outside of the department

• Performs other tasks and assignments as needed and specified by management.

• Assist in the delivery of support to the BioMetric’s Department by working closely with the PTC IT, Finance, Contracting, and Legal  Departments to provide exceptional support and quick turn-around times.

• Participates in the assessment, selection, and evaluation of vendors.

• Ability to quickly understand and triage support questions and ensure that corrective actions are taken and confirm that the issues are resolved on a timely basis.

• Creates/Reviews and revise process documentation including SOPs and Work Instructions.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

* Minimum level of education and years of relevant work experience.

• Bachelor’s Degree and a minimum of 2 years of relevant experience OR an Associate’s Degree and minimum of 4 years of related professional experience OR equivalent combination of experience and/or education.

• Relevant experience is defined as experience in pharmaceutical, biotechnology, CRO, university medical center or related environment.

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

• Experience supporting large departments/groups in a fast-paced, dynamic, multicultural, international environment.

• Demonstrated proficiency using the advanced functionality of Microsoft Office (Power Point, Excel and Word).

• Excellent verbal and written communication skills.

• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

• Detailed oriented and service minded.

• Analytical thinker with excellent problem- solving skills and the ability to adapt to changing priorities and deadlines.

• Excellent planning, organization and management skills including the ability to support and prioritize multiple projects. 

• Ability to handle confidential information with discretion.

• Flexibility to work outside of core business hours when necessary.

• Embraces new challenges or changed priorities and adjusts plans and priorities accordingly.

• Experience working in a fast growing and entrepreneurial environment.

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

• Experience providing support for the administrative tasks associated with a clinical research/clinical operations function.

• Experience with contract management software (i.e., Contracts 365) and service procurement systems (i.e., SAP Ariba).

• Basic understanding of GxP regulations and of Data Integrity.

* Travel requirements

• Up to 15% travel if not local to New Jersey

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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