Specialist II, Clinical Data Management

Specialist II, Clinical Data Management

Title

Specialist II, Clinical Data Management

Our Culture Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held
company with the ability to have an innovative and long term view. Our focus is on
scientific discoveries that improve patients' lives and we equate success as a
pharmaceutical company with the steady introduction of truly innovative medicines.
Boehringer Ingelheim is the largest privately held pharmaceutical corporation in
the world and ranks among the world's 20 leading pharmaceutical corporations.
At Boehringer Ingelheim, we are committed to delivering value through innovation.
Employees are challenged to take initiative and achieve outstanding results. Ultimately,
our culture and drive allows us to maintain one of the highest levels of excellence
in our industry.
Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc.,
Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc., Roxane Laboratories Inc.,
Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc. and
Ben Venue Laboratories Inc., is an equal opportunity employer. M/F/D/V
Description

Boehringer Ingelheimis currently seeking a highly motivated, innovative and results-driven individual to join ourData Managementdepartment located at ourRidgefield, CTfacility. As aClinical Data Manager/Clinical Database Developer you will support the development process for new substances and development and promotion of drugs on the market through provision of the expertise in the field of clinical data management. The person working in this function acts as Trial Data Manager for one or more trials of phase I to IV, the focus on simple trials within the standard setting using BI SOPs, guidelines and working instructions.

The Trial Data Manager (TDM) is a member of the Clinical Trial Team and is responsible for the structure of the trial database and in close co-operation with the Trial Statistician (TSTAT) and Trial Clinical Monitor (TCM) for the accuracy of the content of the trial database. The TDM collaborates closely with the Project Data Manager (PDM) to implement project standards and a harmonized approach to all data management issues within the trial.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.


Duties & Responsibilities:
* The TDM reviews the trial protocol, design and develops electronic Case Report Forms (CRF) layout.
* The TDM programs, tests and maintains plausibility and consistency checks for the trial database based on BI and project standards.
* Together with the TCM and the TSTAT, the TDM initiates and compiles the Trial Data Management and Analysis Plan (TDMAP) that contains all the necessary BDM documentation for a trial.
* During the conduct of the trial the TDM is responsible for monitoring the data entry, discrepancy management, reconciliation of serious adverse events (SAE) with the drug safety database, and for data cleaning activities(completeness, plausibility and consistency) according to the respective SOPs
* During the conduct of the trial the TDM is responsible for integration of external data from vendors or other departments into the clinical trial database.
* The TDM initiates the Medical and Quality Review Plan (MQRP) and conducts Medical and Quality Review Meetings (MQRM) together with the TCM and TSTAT in order to assess patients' safety and to monitor the data flow and quality throughout the conduct of the trial.
* The TDM is responsible for developing listings, tables and graphs in JReview to support all activities of data review.
The TDM participates in the Blinded Report Planning Meeting (BRPM), performs the final reconciliation of serious adverse events with the drug safety database and initiates and chairs the database lock meeting.

Requirements
Required Education & Experience:
* Bachelors (BS) or Masters (MS) in computer science or health care area with minimum of 2 years of clinical data management or related experience in a pharmaceutical, CRO or academic sites.
* Good understanding of data processing skills, programming in the clinical trial area in developing and managing clinical database design or basic SAS programming skills and elementary statistics knowledge in the drug development process.


Desired Experience, Skills and Abilities:
* Experience in database design and development in Oracle Clinical/ Clintrial orother industry clinical data management systems.
* Experience with data review in JReview preferred.
* Good knowledge of FDA, EMA, ICH guidelines and Good Clinical Practices (GCPs) including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.
* Strong organizational skills, problem-solving abilities, time management skills. Ability to work on several assignments simultaneously. Must be able to work independently as well as part of a team. Good written and oral communications skills in the English language.
* Must be precise, detail oriented, and able to detect subtle inconsistencies in the data.
Eligibility Requirements:
* Must be legally authorized to work in the United States without restriction.
* Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
* Must be willing to take a drug test and post-offer physical (if required)
* Must be 18 years of age or older

Boehringer Ingelheim isfirmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings. Boehringer Ingelheim is an equal opportunity employer. M/F/D/V
Division BIPI
Category Clinical Research (Medicine & DRA)
Req ID MD00112
Num Openings 1
Date Posted 1/18/2012
Type Full-time
Location CT, Ridgefield










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