Clinical Data Lead Jobs

Experience with MDM (Master Data Management).

Data & Analytics leader with 15+ years of industry experience.

At least 5 years of experience with clinical trial domain experience is required.

Experience with modern cloud analytics platforms such as Snowflake and/or Databricks is required.

Some MDM experience will be highly desirable.

Experience with ADF (Azure Data Factory) will be desirable.

Minimum 3-5 years of experience in a pharmaceutical/CRO setting with at least 3-4 years of experience in Data Management.

Liaise closely with the Lead Data Manager to report study progress and any issues outstanding.

Assist the Lead Data Manager with the preparation of study documentation.

Assist the Lead Data Manager with the creation and validation of Manual and SAS checks.

Proficient knowledge of CDISC CDASH and SDTM terminology

Attend study update meetings or calls with the study sponsor as needed.

Maintains patient tracking spreadsheets to ensure data entry requirements are met.

Responsible for prompt and accurate data entry for protocols, including Serious Adverse Events.

FULLY REMOTE | CLINICAL DATA COORDINATOR | EAST COAST | APPLY TODAY

Assists in the coordination of initiation, site evaluation, monitoring visits, and audits required by the sponsor.

Works with research team in managing the visits of active and follow up subjects on research protocols.

Processes study specific data collection documents into case report forms.

At Least 3 years of experience in clinical data management and computer savvy. Some project management skills are needed.

Clinical data management experience needed.

They must be open to do menial tasks if they have 5 years experience.

Hybrid role (4 days onsite and 1 day remote)

A team player and flexible; quick and eager to enter into ADC.

Product: a sensor that will b put on the patient

Proven experience with research as well as knowledge of best practices for HIPAA, consent, GCP, FDA, SOP, safety monitoring, and others.

Competitive wage plus great benefits - medical/dental/vision, 401(k) match, etc.

Ensure compliance, create reports, and prepare for sponsor and regulatory manager visits.

Bachelor’s degree in related science field or equivalent amount of clinical research experience in the given study area.

CCRA, CCDM, CCRC, or CCRP certification required.

Strong communication skills and ability to collaborate with a team.

- Exp with Clinical research trial documentation and clinical data management.

- Experience with clinical research trials in med devices.

- Experience using any kind of online eTMF(Electronic Trial Master File).

- Working knowledge of Microsoft office tools - Excel, word, outlook.

- Knowledge knowledge on using statistics.

- SAS experience is nice to have (running the program).

Pharmacy technician certification plus 2 years related work experience, or 4 years related work experience.

Demonstrated ability to effectively communicate with management and other team members

Demonstrated ability to apply pharmacy knowledge and experience in critical thinking and problem solving; ability to recognize discrepancies in data

Perform data normalization prior to data entry, using controlled terminology and following strict editorial guidelines

Strong computer skills; familiarity with Microsoft Office products (e.g., Word, Excel, Access) and Adobe Professional

Solid knowledge of internet searching and pharmaceutical terminology

Primary Duties and Responsibilities include the following:

4. Develop, institute and manage initiatives and strategic plans in response to trending data

7. Manage employee and departmental timeliness and progress during development and implementation of new initiatives

8. Measure and manage staff compliance with new processes and overall success of programs

12. Maintain clinical department files for staff credentialing, licensure and education

14. Manage departmental schedules and communications

Ensures data management activities are conducted in accordance with ICH/GCP, internal SOPs and Work Instructions, and meet all regulatory requirements

Clinical Data Management 3+ years’ experience across Phase 1-4 clinical trials

Creates and maintains project documentation, including, but not limited to, Data Management Plan, CRF Completion Guidelines and validation specifications

Prepares and distributes project status reports to project team and management

Prepares and reports query trends and data/query/CRF completion/missing pages/SDV metrics to the Study Management Team (SMT)

Advanced written, oral, and interpersonal communication skills, including proficient knowledge of medical terminology

Required experience as a clinical data professional with knowledge of clinical regulatory regulations and data management.

3 years of clinical research data management experience is required.

Assist the clinical research team in day-to-day operational activities of data management.

Support internal clinical data management initiatives.

Excellent communication and analytical skills, and a bachelor's degree in a related field.

Working knowledge of studies software is required.

Previous management and leadership experience of clinicians providing support to youth and young adults (digital experience preferred)

Supports the safeguarding team in embedding processes within service delivery, including risk management, risk reporting, and risk prevention.

Significant experience in clinical practices with children and young people within one or more therapeutic modalities.

Experience with leading clinicians in a clinical setting (digital experience preferred).

Excellent Medical, Dental, and Vision benefits

Clinical Lead | Full- Time, Remote

Strong organizational skills with experience balancing priorities and resources

Working closely with Clinical Leads and Project Managers to ensure all data is uploaded and entered in a timely manner

Strong skills in the use of technology, tools, operating systems, and software and is comfortable using these daily

Experience with electronic data capture (EDC) systems, including Oracle Clinical and/or Medidata Rave

2.Data Entry: You will be responsible for all data entry

6.Misc. Responsibilities as needed or required by projects.

Bachelors + 4 Years Data Management Experience OR Masters and 2 Years of Data Management

Develop and review data management procedures for clinical trials with sponsor companies and other departments;

Design reports and metrics that are useful management tools for your projects;

Attend and participate in teleconferences and face-to-face meetings with sponsor companies as the lead representative from data management;

May provide project data management training as needed regarding CRF Completion or EDC system usage;

Coordinate overall data management by serving as primary contact for the sponsor, external data providers, and all project team members

Strong communication and time/project management skills

Minimum 3 years of bio/pharmaceutical experience in Clinical Pharmacology and Pharmacometrics

The U.S. Food and Drug Administration (FDA) approved RELYVRIO™ in September of 2022

Health Canada approved ALBRIOZA™ with conditions in Canada in June of 2022

AMX0035 is currently under review with the European Medicines Agency

280 employees globally, with headquarters in Cambridge, MA, US and Amsterdam, the Netherlands -- and growing strong!

Direct experience with Clinical Research, operations, and Management

Provide operational feasibility/site management input to the development of the protocol, manual of procedures, informed consent template and data validation plan.

Proactively identify potential/actual issues and risks, bring up to management as appropriate, and contribute to mitigation

U.S. Development Medical Device Trial Management

Bachelor’s Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)

5 Years of Relevant Experience

With oversight from Lead Data Manager, issue and manage queries in the EDC database

Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho’s.

Review protocols and apply protocol-specified guidelines to the structure, review, and cleaning of clinical data

Support study set-up, including EDC build (forms, edit checks, and study structure) and validation UAT testing

Build EDC forms from protocol or source document specifications

Build/program EDC edit checks from specification documents

Knowledge / Skills / Abilities:

Participates in internal/sponsor meetings and training programs, as required, working directly with the assigned project manager to provide data management support

Manages project resources according to budget and notifies project manager and supervisor of any potential out-of-scope requests from clients

Must have experience with DM start up, maintenance and closeout activities in both paper and EDC studies

Experience in moderate to complex projects, paper based and EDC Databases. Some global project experience preferred

Requires excellent oral and written communication skills to interact with investigative sites, sponsors and vendors and to build rapport with each

Minimum of 4+ years of relevant clinical data management experience in the pharmaceutical/biotech industries and college degree

Strong communication skills required, and experience working remotely is highly preferred

Experience performing clinical data review and data reconciliation, as well as handling review and reconciliation of data discrepancies

Good working knowledge of ICH, FDA, and GCP regulations and guidelines

Expertise working within the Medidata RAVE EDC system

Must be based on the East Coast and/or able to accommodate full East Coast working hours

2. Maintains & builds awareness of internal and external clinical Data Management practices to enhance domain expertise

26. Excellent Technical skills, start-up knowledge is must

28. Project management & result orientation

3. Single point of contact for Study Data Manager / designee

16. Provide regular status reports to TCS Group Lead and Study Data Manager (SDM)

18. Communicate between different stakeholders and Study Data Manager (SDM)