Hybrid (listed in priority) Clinical Data Manager and SAE Reconciler

Be able to perform, supervise and coordinate all aspects of clinical trial data.

Work closely with Clinical Operations, Clinical Science, Biostatistics, Drug Safety/Risk Management, and CROs.

Manage company DM expectations of the CRO.

Review safety and medical information, including safety components of protocols and studies.

Be able to distinguish between medical concepts and diagnoses.

Need to be able to interpret and apply SAE/Coding/DM Guidelines and Data Handling Guidelines.

Responsible for study startup documents, data cleaning, DCF tracking, medical terms coding, database QC, compilation and maintenance of data management binders, AE reconciliation, and database lock.

Responsible for the quality and timeliness of all data management activities for a study, especially SAE and coding related tasks.

Facilitate DCF resolution interacting directly with monitors and investigator sites.

Identify errors and inconsistencies in CRF data and ensure their resolution.

Author DCFs for SAE recon, Coding, and Re-queries with strong considerations of the site’s perspective.

Responsible for monitoring, tracking, assimilating and communicating AE/SAE/Mortality events and coding information, status, and discrepancies.

Develop and monitor study metrics, ensure appropriate training for the project team, and represent data management at investigator and team meetings.

Represent and/or chair functional/operational meetings.

Prepare material for presenting at inter-departmental or investigator meetings.

May lead and direct the work of others.

Assist other Data Managers with operational tasks on other protocols.

Assist in standardizing data management procedures such as documentation for departmental operating procedures.

Reports to Director, Data Management.

Bachelor's degree and 5+ years of relevant data management experiences in biotech or pharmaceutical industry or CRO, including experiences in various phases of drug development.

CRO management experience is desirable.

3+ years SAE reconciliation.

Intermediate SAS programming skills.

Familiar with industry concepts, practices, and procedures.

Demonstrated leadership quality and superior organizational and interpersonal skills.

Relies on extensive experience and judgment to plan and accomplish goals.

A wide degree of creativity and latitude is expected.

Be able to work independently.

Knowledge of medical terminology, OC a plus.

Coding experience using MedDRA and WHODrug a plus.

Pulmonary and/or Infectious Disease trial experience a plus.

InterMune is an equal opportunity employer.

Please reference requisition number:CLN 07037/07038 when applying for this position.