HonoluluRecruiter Since 2001
the smart solution for Honolulu jobs

Senior Clinical Data Sciences Lead

Company: DOCS
Location: Honolulu
Posted on: April 9, 2021

Job Description:

Senior Clinical Data Sciences Lead **Ref #:** 27083 **Employment type:** Permanent - Full-Time **Location:** US - Nationwide **Posted:** 19-Feb-2021 **Description** At DOCS, we care about our people and their passion, as they are the key to our success and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career. We have over 4500 employees globally working on novel therapies that deliver real impact to patients in need. All our team members have the independence to get the job done and support from the experienced leadership team when you need it. If you want a career with a difference, DOCS is the place for you. General: Leading Data Management including centralized monitoring related activities within a complete clinical development program (Phase I-IV, Accountable and Project Leadership) for global or regional trials and/or programs with different complexity Is recognized as an expert within the discipline and beyond, with peers within the same technical area in the business as well as other key business functions Serving as the escalation point, work with CRO data managers, vendors, internal team members for resolution Serves as best practice resource within own discipline or as technical expert on cross-functional teams or projects Has in-depth organizational and relevant market knowledge and uses understanding on how relevant areas can be integrated to achieve objectives. Ensures and tracks data quality of clinical database/deliverables (incl. CRF and non-CRF data) and submission readiness of the clinical data management deliverables and data packages (e.g. CDISC) Project management of all clinical data management related deliverables by ensuring adherence to planned time, cost and quality Execution of the clinical data collection strategy in accordance to Merck Standards (Data Collection, SDTM (CDISC)) as applicable Accountable for oversight of CROs in the execution of Phase I IV clinical trial(s). Represents Data Management within the Global Trial Team and serves as the key Clinical Trial Execution point of contact for the DM related tasks in a trial/project/program Key contributor to the development of reports and communicating to relevant line management and Clinical Operations Teams Drives and leads the successful execution, oversight and approval of all DM related clinical trial documents and operational plans (e.g. Data Management Plan) of clinical trials using strong project management, leadership, and organizational skills Ensures strong oversight, review and delivery of trial/project DM related CAPAs in order to meet corporate compliance standards and timelines Accountable for partnering with CRO in DM related audit responses and addressing quality issues. Provides leadership and contributes to all operational aspects of the DM related trial budget, including forecasts to ensure delivery within the R&D financial standards Performs review and provides strong operational input in the development of Clinical Trial Protocols, Integrated Analyses Plan and CSRs Filters, prioritizes, analyzes and validates complex and dynamic information from a diverse range of external and internal sources to respond to technical operational and organizational challenges Supports the development and implementation of department initiatives including input on SOPs, processes, and work-streams Senior Clinical Data Sciences Lead: Impacts as Program Data Manager projects/work streams with moderate complexity, risk, impact and reach. Impacts medium-sized global project teams with members also from outside the direct working environment. Coordinates stakeholders from closely related areas or even beyond Demonstrates skills in successfully leading international teams in the matrix organization and direct, influence and motivate people; contributes to a positive working climate Coordinates operational and therapeutic area training for internal and external study team members. Accountable for successful project execution including definition of milestones. May also include clarification of project scope. Receives minimal guidance or works independently. Acts as an advisor and mentor within the team and beyond and may serve as best practice resource within own discipline or as technical expert on cross functional teams or projects Serving as primary point of contact for any HA submission related activities (e.g. preparation of briefing books, attending HA meetings as requested) Leads the development of clinical data collection strategy in accordance to Merck Standards (Data Collection, SDTM (CDISC)) as applicable Initiates and leads process and technology improvement and re-engineering initiatives To represent the GCDS line management when requested Strategic Impact Defines KPIs, Drives KPI improvement, Derives KPIs from project management tools and planning sheets Impact on delivery of submission relevant data to health authorities in Key Development projects Significantly contributes to a high priority project (NPV > EUR 800 m, expected peak year sales > EUR 700 m, yearly development costs - EUR 25-100 m). Team member of the Clinical Operations Team and Program Team as applicable Defines and ensures Data Strategy, Data and Therapeutic Area Standardization across a complete Clinical Development program to ensure data pooling, successful submission management. Key role in contributing to fast decision-making in clinical programs. Initiates and leads process and technology improvement and re-engineering initiatives Defines KPIs, Drives KPI improvement, Derives KPIs from project management tools and planning sheets Budget Management o Trial and project budget related to data management (multimillion EUR for large and complex trials) o Budget of data sciences projects and other projects up to 5 Million EUR Work Experience Experience in all aspects of Data Management related clinical study planning and execution, and in executing the complete range of clinical study activities, from concept sheet through final study report and archiving Proven experience as Clinical Data Manager in the pharmaceutical/biotechnology industry, equivalent to 8 years Substantial project management experience DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry. DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

Keywords: DOCS, Honolulu , Senior Clinical Data Sciences Lead, Healthcare , Honolulu, Hawaii

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Healthcare Jobs


Pediatric Intensive Care Unit - PICU Travel Registered Nurse
Description: Travel Nurses Needed - Pediatric RN Specialties br Nationwide Pediatric Travel Nursing JobsPediatric Intensive Care Unit, Pediatrics, Pediatric OncologyHCEN has numerous request for RN Candidate Profiles (more...)
Company: RN Travel HealthCare Jobs
Location: Honolulu
Posted on: 04/17/2021

CVOR Travel Nurse
Description: Since 2001, we've helped nurses travel the country.
Company: Cariant Health Partners
Location: Honolulu
Posted on: 04/17/2021

Registered Nurse (RN) - Home Health Visits
Description: BAYADA Home Health is looking for a compassionate and dedicated Registered Nurse RN to join our team in our Oahu office. This office services our adult and geriatric clients on a per visit basis in (more...)
Company: BAYADA HOME HEALTH CARE
Location: Kaaawa
Posted on: 04/17/2021


Emergency Department RN - ED/ER Nurse Assignments
Description: Emergency Department RN - Assignments Nationwide Travel Nurse Are you looking for a new nursing job Would you like to spend the season somewhere you've never been Hospitals nationwide are looking for (more...)
Company: HealthCare Traveler Jobs
Location: Pearl City
Posted on: 04/17/2021

Licensed Health Insurance Agent - On-Demand, Remote, Flexible Sales
Description: Assurance, a Prudential company, is hiring Under 65 Health Insurance Sales Agents in your city. If you're already a Licensed Insurance Agent have a Residential Insurance License, we want to hear from (more...)
Company: ASSURANCE Independent Agents
Location: Waimanalo
Posted on: 04/17/2021

Hospitalist
Description: br br JOB DETAILS br br br br Envision Physician Services is seeking full-time Hospitalists to join our team in Ewa Beach, HI. We have immediate openings. br Hospitalist Program br ul (more...)
Company: Envision Physician Services
Location: Ewa Beach
Posted on: 04/17/2021

Registered Nurse (RN) - Weekend Home Health Visits
Description: BAYADA Home Health is looking for a compassionate and dedicated Registered Nurse RN to join our team in our Oahu office. This office services our adult and geriatric clients on a per visit basis in (more...)
Company: BAYADA HOME HEALTH CARE
Location: Kaaawa
Posted on: 04/17/2021

PT - Physical Therapist
Description: PT - HH - HI - ASAP - br br - br br CoreMedical Group has hundreds of exciting and rewarding travel assignments throughout the country for Travel
Company: Core Medical Group
Location: Honolulu
Posted on: 04/17/2021

Travel RN-Telemetry - Honolulu, HI
Description: Telemetry opening in Honolulu, Hawaii. This and other rn jobs brought to you by NursingJobCafe.com ul li RNnetwork has an excellent travel opportunity for a provider
Company: RNnetwork
Location: Honolulu
Posted on: 04/17/2021

Caregivers (No Certification required to apply!)
Description: CAREGIVER/NURSE AIDEWilson Homecare is excited to invite anyone with hands-on experience taking care of a loved one to join our team
Company: Wilson Care Group
Location: Honolulu
Posted on: 04/17/2021

Log In or Create An Account

Get the latest Hawaii jobs by following @recnetHI on Twitter!

Honolulu RSS job feeds