Medical Science Associate

Location: Amsterdam, Netherlands

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Workplace Type: Remote

The Medical Science Associate reviews and analyses project specific medical data; supports medical monitors in all study-related activities including the preparation of medical plans, trainings etc.  The Medical Science Associate manages study-related committees such as Data Monitoring Committees (DMCs), Data Safety Monitoring Boards (DSMBs), and Adjudication Committees.  The Medical Science Associate manages daily operations of the Medical Operations department while participating in process development and improvement to increase the overall efficiency of the entire Medical group.

Responsibilities: 

  • Performs review of medical data listings, line and lab listings with further analysis, data mining and safety trends detection; highlights areas for medical review
  • Performs review of a study-specific Case Report Form (CRF) and medical coding
  • Performs initial assessments for Medical Eligibility and Enrollment Review process
  • Assists Medical Monitor(s) with creation of Medical Management Plans and other study-related medical documents including but not limited to plans related to Medical Data Review, Endpoint Management, and Eligibility Review.
  • Assists Medical Monitors with the development and conduct of study-related medical trainings; provides the maintenance of the internal medical trainings database.
  • Functions as primary interface between Company and sponsors, vendors, and other departments in the area of DMC, DSMB, Safety Committee, and Adjudication Committee management. Provides specialized knowledge for international guidance regarding the conduct of study-related
  • Facilitates Medical documents management and archiving including
  • Works with the Proposals department in the development of RFPs and proposals by providing budgets and text related to the requested medical services.
  • Develops, or oversees the development of, work orders and change orders for projects involving Medical Operations.
  • Supports operations of the medical team by:
    • Identifying issues on the department’s operating budget and analyzing internal reports to track the budget throughout the fiscal year;
    • Researching historic budget information and utilizing it to initiate change orders when necessary or improving budgeting estimates;
    • Maintaining Standard Operating Procedures (SOPs) and participating in the review and improvement of other related SOPs.
  • Provides training for Medical team and company on new procedures and
  • Develop and facilitate Medical process implementation (template, work flow)

Qualifications: 

  • MD/RN/ and BA/BS in the biological sciences or related discipline in the natural sciences/health care field, nursing degree, or equivalent combination of education and experience. MS in a Healthcare, Business Administration, Public Administration, Public Health, or equivalent degree
  • Requires a minimum of two (2) years of clinical research experience in the pharmaceutical industry and related therapeutic specialties preferred.
  • Possesses knowledge of, and ability to, apply GCP and all applicable regulations and
  • Knowledge of financial budgets and various financial analysis
  • Superior proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, MS Project), email, and
  • Strong presentation skills, interpersonal skills, as well as a team oriented Excellent verbal, written, and communication skills. Ability to multitask under tight deadlines while providing attention to detail and high quality work.
  • Ability to be flexible, adapt to change, work independently, as well as work in a matrix

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation.  Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.

EEO Employer Verbiage:

At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity

It is Advanced Clinical’s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.

This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.