
Senior Clinical Data Manager
21 hours ago
The Senior Clinical Data Manager (SCDM) is responsible for performing and assisting in data management activities like EDC build, coding, query management, external data reconciliation, SAE reconciliation, EDC testing and writing test scripts, and data cleaning. Act as backup to Lead Clinical Data Manager. If required, lead studies independently.
Support LDM in managing the work of outsourcing vendors and support LDM in approving the following key standard study documents: CCGs, Raw Data Validation Checks, User Acceptance Testing documents, eCRF development, and DB lock plans. Approve the key documents in the absence of LDM.
The Senior Clinical Data Manager should thoroughly understand the requirements for Good Clinical Data Management services, including its documentation; be willing to be involved in start-up or wrap-up of in-house and client-specific data management projects; have an understanding of the relevant therapeutic indications, study hypotheses, and trial design; and have a solid understanding of database design and structure.
Responsibilities:
- Perform and assist in data management activities like data validation, discrepancy review, query resolution, and reconciliation.
- Act as backup to Lead Clinical Data Manager. If required, lead studies independently.
- Support LCDM or independently prepare all study-specific procedures (DMP, CCG, etc).
- Create Data transfer agreements when required.
- Take part in study kick-off (internal and external) meetings.
- Review Case Report Forms (CRFs) and edit checks specifications.
- Ensure all deliverables meet quality standards and customer expectations
- Lead or support LCDM and coordinate other team members, providing guidance and support.
- Communicate with sponsors, sites, and other departments to facilitate data collection and resolve issues if required in the absence of LCDM.
- Assist LCDM in tracking and managing projects, identifying risks, and taking corrective actions.
- May provide training on basic data management expertise to new team members.
- Perform User Acceptance Testing (UAT).
- Provide regular study status updates to the LCDM.
- Support the LCDM in the delivery of study-specific training to all team members, ensuring that the training is documented and the documentation is filed in the TMF.
- Train junior Clinical Data Managers, guide and help them through data management activities.
Qualifications:
- Ability to communicate effectively in the English language in person, by phone, and in writing.
- Ability to lead functional meetings.
- Strong attention to detail and accuracy is a must.
- Excellent organizational skills.
- Demonstrated ability to manage multiple projects.
- Ability to work collaboratively, effectively, and productively in diverse organizational structures.
- Ability to work independently, take initiative, and complete tasks to deadlines: Delivering Excellence, Serving Customers, Accountability and Ownership, Global and Cross-Functional Communication.
- Ability to work in a team-oriented, collaborative environment.
- Ability to work positively within a continually changing environment.
- Ability to effectively prioritize and execute tasks in a high-pressure environment.
- Advanced computer skills and practical knowledge of MS Office and potentially project management software.
Requirements:
- A bachelor's degree in Life Sciences is required.
- 5-7 years of core clinical data management experience is required.
- Prior trial responsibility for the entire data management life-cycle is required.
- Able to work in shifts. 9-6 PM IST for Local clients and 2-11 PM IST for US clients.
- Study start-up and close-out experience is mandatory.
- Experience working on different EDC systems (Medidata Rave, Veeva EDC, Oracle EDC, Medrio, etc)
- Experience in multiple vendor reconciliations (Lab, ECG, PK, etc.) and integrations (IRT, Lab, and ECG integrations, etc.
- Prior Study lead experience will be preferred.
- Working knowledge of EDC studies is required, and SAS is preferred.
-
Clinical Data Management Professional
7 days ago
San Fernando, Central Luzon, Philippines beBeeData Full timeJob Title: Senior Clinical Data Manager">The Senior Clinical Data Manager plays a pivotal role in the data management lifecycle, overseeing various activities to ensure the integrity and quality of clinical data.Key Responsibilities:Lead and assist in data management activities like validation, discrepancy review, query resolution, and reconciliation.Act as...
-
Data Analysis Professional
2 days ago
San Fernando, Central Luzon, Philippines beBeeStatistical Full time ₱50,000 - ₱100,000Statistical Programmer RoleWe are seeking an experienced Statistical Programmer to join our team.Develops and maintains statistical programming protocols for clinical studies, ensuring accuracy and compliance with regulatory requirements.Creates high-quality SAS programs and procedures to extract, manipulate, and analyze data from various sources.Analyzes...
-
Biostatistician II
2 days ago
San Fernando, Central Luzon, Philippines Scrubbed Full timeBiostatistician II at ScrubbedBiostatistician II role involving statistical analyses for clinical research studies as outlined in statistical analysis plans, including creating statistical graphics and verifying randomization codes. Responsibilities include preparing statistical sections of protocols (including sample size calculations), annotating shell...
-
Lead Biostatistical Researcher
2 days ago
San Fernando, Central Luzon, Philippines beBeeBiostatistician Full time ₱900,000 - ₱1,200,000Senior Biostatistician PositionThis is an exciting opportunity to lead our biostatistical team and contribute to the design, planning, and execution of clinical research studies. As a Senior Biostatistician, you will be responsible for conducting advanced statistical analysis, developing statistical analysis plans (SAPs), and preparing statistical sections...
-
Statistical Programming
2 days ago
San Fernando, Central Luzon, Philippines Scrubbed Full timeJoin to apply for the Statistical Programming role at ScrubbedResponsibilitiesPrograms all tables, listings and graphs necessary for an assigned clinical study report (CSR)Programs customized data displays, (including data listings, summary tables and routine graphics) in accordance with the approved statistical analysis plan (SAP) and shell displays for...
-
Biostatistician I
21 hours ago
San Fernando, Central Luzon, Philippines Scrubbed Full timeOverviewBiostatistician I statistical analyses for clinical research studies as outlined in statistical analysis plans, including creating statistical graphics and verifying randomization codes. They prepare statistical sections of protocols, including sample size calculations, annotate shell data displays, and provide specifications for the structure,...
-
Sr Project Manager
2 days ago
San Fernando, Central Luzon, Philippines HiPaaS Infotech Pvt Ltd Full timeOverviewSr. Project Manager with strong experience in eClinical suite implementation (Strategic delivery role).Location - Anywhere in India/RemoteRate – rate is open and flexible - give me your best rates - right skills is impEngagement Type: Strategic delivery role eClinical suite implementationRole Overview: The PM will lead the planning, execution, and...
-
Statistical Data Analyst
2 days ago
San Fernando, Central Luzon, Philippines beBeeBiostatistician Full time ₱600,000 - ₱800,000Job OverviewWe are seeking a highly skilled Biostatistician to join our team. The successful candidate will be responsible for conducting statistical analyses for clinical research studies, creating statistical graphics, and verifying randomization codes.
-
Accounting Senior Manager
6 days ago
San Fernando, Central Luzon, Philippines Scrubbed Full timeJoin or sign in to find your next job Join to apply for the Accounting Senior Manager role at Scrubbed 1 week ago Be among the first 25 applicants Join to apply for the Accounting Senior Manager role at Scrubbed Get AI-powered advice on this job and more exclusive features. The Senior Accounting Manager plays a key leadership role in...
-
Research Analyst
13 hours ago
San Fernando, Central Luzon, Philippines beBeeBiostatistician Full time ₱400,000 - ₱800,000**Job Title:** Biostatistician IWe are seeking a highly skilled Biostatistician I to join our team. The ideal candidate will have a strong background in statistical analysis and experience working with clinical research studies.The Biostatistician I will be responsible for performing statistical analyses, creating statistical graphics, and verifying...