Clinical Data Manager (Contractor)

Loxo Oncology, Inc. • Stamford, CT 06901

Posted 1 month ago

Job Description

Reports To:

Senior Manager, Clinical Data Management

Position Summary

Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.

The Contract Clinical Data Manager is responsible for overseeing data management tasks from study start-up through database lock for clinical trials. This individual collaborates with the Clinical Trial Managers (CTMs), Biostatistics team, and data management vendors to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final database deliverables are in compliance with standard operating procedures and regulatory agency guidelines. The Clinical Data Manager ensures all Clinical Operations activities stay within full compliance of Loxo regulatory and legal policies.

Roles and Responsibilities of the Position*

* Represents data management in study team meetings

* Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines

* Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols, UAT execution)

* Executes and/or distributes data management metrics, listings, and reports, as required

* Oversight of data management CRO/service providers on assigned studies

* Monitors the progress of all data management activities on assigned studies to ensure project timelines are met

* Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed

* Proactively identifies potential study issues/risks and recommends/implements solutions

* Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, able to work independently towards the assigned goal

* Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables

Required Qualifications and Background

* Bachelor degree in Life Sciences, Computer Sciences, Mathematics, health related field or equivalent experience

* 6+ years of CDM experience in the pharmaceutical or biotechnology industry

* CRO management experience a plus

* Prior oncology/hematology experience highly desirable

* Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements

* Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment

* Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email

* Good working knowledge of ICH, FDA, and GCP regulations and guidelines

* Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint)

* Knowledge of industry standards (CDISC, SDTM, CDASH)

* Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug

* Proven ability to work both independently or in a team setting

Physical Demands / Travel

This position will travel occasionally; the average travel for this position is 10-15% with some variation based upon the demands of the business imperatives.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

The position's work environment is based in a typical office setting with occasional travel required.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

* To perform this job successfully, an individual must be able to perform each roles and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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