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Clinical Document Specialist (302-419)

ARIAD Pharmaceuticals, Inc.

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Location: Cambridge, MA Posted Date: 4/30/2013 Position Type: Full time Job Code: 302 Salary: DOE Required Education: Bachelors Degree Areas of Expertise Desired: Clinical Data Management

Description




ARIAD is a Cambridge, Massachusetts-based biotechnology company focused on cancer. We are a cohesive team of talented people from diverse backgrounds with a shared vision: We seek to transform the lives of patients with breakthrough cancer medicines. This is our purpose. This is our passion. This is our promise.


Job Summary

As a key member of Clinical Operations team, you will support the administrative processing and archiving of documentation generated in the daily management of clinical trials. These activities include: (1) collecting, reviewing, and processing documents into the company trial master file, (2) preparing and maintaining spreadsheets/databases, (3) assisting with the execution of clinical contracts in coordination with the Legal department, (4) managing the distribution of investigational product safety letters, and (5) preparing clinical trial status reports.

This position provides an entry-level opportunity to join a growing Clinical Operations Department, and contribute substantially to the successful execution of Oncology trials with the lead product candidates at ARIAD. In addition, there is an opportunity to build skills in the science of clinical research through day-to-day activities and close interactions with the other departments within Clinical Research and Development. There is an opportunity for growing responsibility and activities commensurate with the individual’s capabilities and eagerness to learn.

Responsibilities

- Primarily responsible for the receipt, review, and submission of clinical trial documents into the company trial master file
- To work closely with safety and medical groups to provide any relevant safety letters to relevant investigational sites participating in ARIAD clinical trials. This includes not only the preparation and shipment of ground-shipping envelopes, but also electronic means
- Preparation and maintenance of spreadsheets and/or databases to track transmittal of key clinical documents
- To prepare and/or format contracts for the use with vendors and sites participating in clinical trials
- Work with Clinical Trial Managers and Clinical Trial Associates to provide study status updates for dissemination within ARIAD to key stakeholders
- Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
- Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization.

Requirements




- Will be an ad-hoc member of multiple Study Teams and will provide support in their conduct of clinical trials.
- Clear and timely communication of study related status and activities that will facilitate the Study Team to efficient study execution and achievement of key milestones.
- Interacts on a daily or as-needed basis with members of the cross-functional ST Interacts on an as needed basis with external personnel (e.g., CROs, vendors).
- Builds relationships across and up and down the organization.
- Study level routine assignments with oversight from the CTM or Manager.
- Follows established SOPs, GCP and other applicable regulatory requirements in the execution of all activities.
- May make decisions related to study documentation management when proficiency with role is demonstrated.
- Strong organizational, analytical and communication skills are required.
- Proficiency with computer systems software such as Microsoft Word and Excel, Sharepoint or other document management systems are desired, however appropriate training will be provided where needed.
- Knowledge and understanding of the clinical trial process and GCP/ICH guidelines are a plus.
- Prior pharmaceutical, clinical or academic research experience is preferred.
- proficient oral and written communication skills, and detail-oriented with strong organizational abilities. Additionally an ability to multi-task, be flexible, and to thrive in a fast-paced environment.
- Excellent interpersonal skills, with a demonstrated ability to work in a team environment as well as independently, are required.
- B.A. degree
- Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
- Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization.


ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.
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