Back to jobs

Associate Director, Data Management

United States - Remote

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity
Praxis is seeking an experienced Associate Director, Data Management to serve as the primary point of contact for data management on assigned studies and programs—driving decisions, resolving issues, and contributing to cross-functional planning and execution.  You will also oversee the performance of external data management partners for assigned studies and programs. This is a hands-on role requiring strong judgment, technical expertise, and a collaborative mindset.  If you are energized by building fit-for-purpose systems, navigating complexity with curiosity and ownership, and working at a company where patients come first, we’d love to meet you.

 

Primary Responsibilities

  • Directly contributes to the oversight of Data Management service providers and external vendors on assigned studies and programs, ensuring milestones and quality deliverables are achieved on time, within budget, and in accordance with regulatory requirements.  
  • Serves as the point of contact for decision making and resolution within and across studies and programs.  
  • Reviews and approves Data Management related documentation for quality, completeness, and accuracy; including but not limited to Case Report Forms, Data Validation Specifications, Case Report Form Completion Guidelines, Data Management Plans, Data Transfer Agreements, Medical Coding Guidelines, User Acceptance Testing (UAT) documentation, Communication Plans, etc. 
  • Performs secondary User Acceptance Testing (UAT) of the EDC system prior to deployment to the production environment. 
  • Contributes to and oversee the development of the Integrated Oversight Plan, establishing an internal cross-functional oversight plan to ensure data quality and demonstrate oversight; conducts DM data review per the plan using appropriate tools and systems. 
  • Ensures the timely provisioning of feedback on draft protocols, risk assessments, and functional area plans and outputs as appropriate (e.g. Medical Monitoring Plan, Statistical Analysis Plan (SAP), Clinical Study Reports (CSR), Tables, Listings and Figures, etc.). 
  • Participate in continual development through the acquisition and enhancement of knowledge related to drug development, clinical trials methodology, and DM best practices, and apply the information to make recommendations for improvement to processes and business performance. 


Qualifications and Key Success Factors

  • Bachelor’s degree required within a scientific discipline, pharmaceutical sciences, engineering, or related field.  CNS experience a plus. 
  • Requires a minimum of 5 years of Clinical Data Management experience in a pharmaceutical or CRO setting; 7+ years preferred 
  • Significant experience in managing outsourced data management activities. 
  • Thorough understanding of the drug development process, clinical trial methodology, regulatory requirements, and GCP. 
  • Current and extensive knowledge of industry Data Management best practices and processes and understanding of Risk Based Quality Management (RBQM) principles. 
  • Strong experience with computerized systems including EDC (preferably Medidata RAVE, Marvin EDC), eCOA, and ePRO. 
  • Experience with data visualization tools (e.g. elluminate, Spotfire) and advanced analytics systems (e.g. Medidata CSA, CluePoints) preferred. 
  • Strong and effective oral and written communication, project management, and interpersonal skills are required. 
  • CCDM is preferred. 
  • Knowledge of SAS and database programming, systems integration experience and understanding of CDASH and CDISC standards are preferred. 
  • The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.

Annualized Base Salary

$165,725 - $190,250 USD

Company Overview 

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance.  At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders.  Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.

Attention: Job Scam Alert
Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com.

Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf


Education

Select...
Select...
Select...

Select...
Select...
Select...
Select...
Select...
Select...
Select...
Select...
Select...
Select...

Authorization

I hereby authorize Praxis Precision Medicines, Inc. (the "Company") or any designated officer, employee, agent, or representative to confer with the references that I have provided consent to contact. I understand that the Company may ask my references questions about my educational background, work experience, achievements, performance, attendance, and reason for separation from former employment, among other things. I expressly authorize my references to answer such questions.

I understand that any information provided by my references will be used solely for the purpose of determining my acceptability for employment with the Company.

I release all named references from any claim of liability or damages, including but not limited to, claims for defamation, interference with contract or business relations/opportunities, and negligence which may arise or result from any information provided by a reference pursuant to this authorization.

Acknowledgement

I certify that all information I have provided in order to apply for and secure work for this Company is true, complete, and correct. All information and documents previously provided to the Company in connection with my application for employment are incorporated by reference herein. I further agree that any information and documents provided to the Company will be true, complete, and correct.

I understand it is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

I understand that any information provided by me that is found to be false, incomplete or incorrect in any respect will be sufficient to (i) constitute sufficient grounds to reject my application for employment without further consideration, or (ii) constitute sufficient grounds to discharge me from employment, whenever it is discovered.

By submitting my application, I expressly authorize, without reservation, the Company, its representatives, employees or agents to contact and obtain information from all references (personal and professional), employers, publishing agencies, licensing authorities and educational institutions and to otherwise verify the accuracy of all information provided by me, including but not limited to information in this application, in my resume, or during a job interview.  I understand Praxis will not contact my current employer without consent prior to acceptance of an offer of employment. I hereby waive any and all rights and claims I may have regarding against the Company, its agents, employees or representatives for seeking, gathering, verifying and/or using such information in the employment process.

I understand that this application remains current for thirty (30) days. At the conclusion of that time, if I have not heard from the Company and still wish to be considered for employment, it will be necessary to reapply and fill out a new application. If I am hired, I understand that I am an at-will employee who is free to resign at any time, with or without cause or notice, and that the Company reserves the same right to terminate my employment at any time, with or without cause or notice, in accordance with applicable law. I understand that if I choose to voluntarily terminate my employment, the Company may either permit me to continue my employment during the notice period or accept my resignation immediately. This application does not constitute an agreement or contract for employment for any specified period or definite duration. I understand that no supervisor or representative of this Company is authorized to make any assurances to the contrary and that no implied, oral or written agreements providing any specified period or definite duration of employment are valid unless they are in writing and signed by the Company’s president.

In the event I am hired, I agree to comply with all rules, policies, and procedures set forth in the Company's corporate policies, employee handbook or other such communications distributed to all employees.

I also understand that if I am hired I will be required to provide proof of my identity and legal authority to work in the United States and that federal immigration laws require me to complete an I-9 Form in this regard.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. 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.

As set forth in Praxis Precision Medicines, Inc. ’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
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 the 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.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, 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?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

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.