Description

The Clinical Data Manager is responsible for the oversight and management of all clinical data management activities from study start-up through database lock for multiple clinical studies. The Clinical Data Manager will interact well with the RefleXion Clinical Affairs team and collaborate effectively with RefleXion staff, vendors, clinical research coordinators, and principal investigators to ensure clinical data management activities meet or exceed the expectations for timelines and quality standards.

The Clinical Data Manager will have demonstrated experience in managing clinical study data, exceptional organizational skills and will be comfortable working in a fast-paced environment.   

Responsibilities

  • Performs Clinical Data Management tasks from study start-up through database lock for clinical studies.
  • Manages study data management schedule and ensure completion of data management deliverables per study timelines.
  • Develop and maintain study-specific data management documentation and procedures including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Edit Check Specifications, Coding Guidelines, Change Control Documentation, Database Audit and Lock Procedures.
  • Develops and/or oversees the development of clinical study database by the EDC/CRO vendor.
  • Perform and/or participate in User Acceptance Testing (UAT).
  • Reviews data listings and issues queries.
  • Leads and/or participates in database clean-up and database lock activities.
  • Maintains effective working relationships with internal study team, study site personnel, and vendors including CROs, core labs, consultants.
  • Collaborates with Biostatisticians, Safety representatives, and other team members as required.
  • Organizes and files applicable clinical study documents per Study Master File Index (SMFI).
  • Other duties as assigned.

Requirements

  • Bachelor’s degree.
  • 5+ years of Clinical Data Manager experience required.
  • Proficiency with multiple electronic data capture systems required.
  • Experience in medical device and oncology studies is highly desirable.
  • Willing to travel up to 20%.

Company Benefits and Perks – What you will love about us!

All positions at RefleXion are eligible to receive the same benefits, listed here. We also want to highlight the following perks that add to our collaborative and team-work company culture.  As we continue to grow as a company, we strive to have these benefits and perks grow with us – we are so excited for what is in store! 

  • The opportunity to work with a passionate, driven team in a pre-IPO start-up environment
  • Competitive compensation and stock option package
  • Three (3) weeks PTO to start
  • Medical (both HMO and PPO options), Dental and Vision
  • Health Savings Account (HSA), Flexible Spending Account (FSA), Dependent Care Flexible Spending Account (DCFSA)
  • Employee Assistance Program (EAP)
  • 401K
  • Employer paid Life Insurance
  • RefleXion Benefit Hub – for company exclusive discounts and deals on a variety of sites and items
  • Free daily on-site lunches
  • Kitchens filled with a variety of healthy and delicious snacks and drinks – including espresso and soda machines!
  • Company culture building events such as Coffee Chats with the Executives, Friday Afternoon Ice Cream Socials and monthly Book Club
  • On-site mobile car wash services weekly
  • Electric car charging stations on site

 

Apply for this Job

* Required
  
Attach Dropbox Google Drive Paste
  
Attach Dropbox Google Drive Paste

U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at RefleXion Medical 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.

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.

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:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • 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

1Section 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.