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Senior Data Manager

Company: Dicerna
Location: Cambridge
Posted on: September 15, 2020

Job Description:

We are not satisfied with the status quo. We interfere with the genes responsible for disease. We break down barriers to progress, partnering with the best and the brightest inside and outside our company to do what is right for patients.

As innovators in the emerging field of RNAi, we seek fellow revolutionaries – independent thinkers to join our growing team, advance our robust pipeline of therapies and provide ground-breaking medicines to those who need it most.

Our office locations in Cambridge, Massachusetts, and Lexington, Massachusetts, as well as our facility in Boulder, Colorado, provide proximity to world-class research, academic and healthcare institutions as well as other life sciences leaders.

We offer competitive salaries and benefits packages and are proud to be an equal opportunity employer.

Our mission We interfere with disease We use RNA interference, or RNAi, to create medicines that silence the genes that cause disease. Our goal is to provide life-changing therapies to people living with rare diseases and common diseases that have a genetic component.

The Senior Data Manager will be responsible for oversight of clinical data management (CDM) activities for assigned programs and/or studies. The successful candidate will proactively oversee CDM execution of CRO outsourced and/or FSP managed trials from study startup through study closure in support of trial objectives and corporate goals. This position reports to the Director of Data Management.

Key Responsibilities

Provide study and/or program-level oversight of clinical data management activities.

Collaborate with clinical study teams and vendors to meet project deliverables, including data acquisition, quality checking and reporting in compliance with GCP, SOPs and regulatory requirements.

Oversee the development of study-specific CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, edit check specifications, and data management plans – identifying and mitigating risks to data quality and proper inclusion into the Trial Master File (eTMF).

Oversee the activities of CRO DM functional counterparts to ensure adherence to scope of work and service agreements, and to ensure deliverables are met in accordance with study milestones/timelines and with quality.

Perform thorough development testing of the eCRF prior to deployment, inclusive of creating or overseeing vendor User Acceptance Test (UAT) Plans, Test Scripts and execute testing as applicable.

Ensure completeness, accuracy and consistency of clinical data across all assigned studies.

Participate in internal study team meetings as well as teleconferences with outside vendors and study personnel.

Report query trends and data/query metrics to the study team.

Review data transfer specifications/agreements for consistency with study and program needs.

Represent data management at Investigator Meetings and may present EDC and Case Report Forms to investigators.

Assist in implementation of key performance and quality indicators.

Track and review key performance indicators on data entry, source verification, and query status; perform quality control on those metrics to ensure accuracy.

Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells.

Review data listings prior to final database locks.

Qualifications

BS/BA in Life Science or related discipline.

3+ years of clinical data management experience in the pharmaceutical/CRO industry. At least 1 year on the sponsor side.

3+ years of Electronic Data Capture (EDC) experience including Medidata Rave.

Global clinical trial and CRO management experience.

Strong working knowledge of FDA & ICH/GCP regulations and guidelines.

Strong knowledge with CDISC (CDASH/SDTM), medical dictionary coding standards, FDA and ICH guidelines, GCP, 21 CFR Part 11, Clinical Data Management best practices.

Experience with SAS or SQL programming techniques with clinical data management application a plus.

Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast paced, team-based environment.

Experience with DIA TMF reference model pertaining to CDM documentation.

Ability to perform limited travel as needed.

U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at Dicerna are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary . Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Gender Please select Are you Hispanic/Latino? Please select Please identify your race Please select Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Veteran Status Please select Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability Why are you being asked to complete this form? We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .

How do you know if you have a disability? You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

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Blind or low vision

Cancer

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Cerebral palsy

Deaf or hard of hearing

Depression or anxiety

Diabetes

Epilepsy

Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome

Intellectual disability

Missing limbs or partially missing limbs

Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)

Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

Disability Status Please select 1 Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Keywords: Dicerna, Cambridge , Senior Data Manager, Other , Cambridge, Massachusetts

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