42199 - Assoc Centralized Monitor

3 weeks ago

Kochi, India IQVIA Full time

Job Overview
Provide project related assistance to assigned project teams. Ensure all work is conducted in accordance with standard operating procedures, policies, good clinical practices and applicable regulatory requirements. Meeting quality and timeline metrics.

Essential Functions
- Complete appropriate role-specific training to perform job duties.;
- Under supervision, provides study level administrative support to the clinical study management team (examples of such tasks include, but not limited to running system reports, preparing and distributing status reports, creating and maintaining study trackers, follow-up for outstanding issues, etc.).;
- Assist in updating and maintaining systems within project timelines/plans and driving tracking compliance in various systems to enable credible data for analysis.;
- Perform the activities as per the task list delegated by CMS leads.;
- Assist CMs in the preparation of i-site pack for their respective sites and countries for assigned studies, by pulling associated reports.;
- Perform centralized monitoring activities on assigned sites and evaluate their quality and integrity as per the protocol, SOPs respective regulation and guidelines.;
- Prepare i-site pack for respective sites and countries for assigned studies.;
- Interact with sites/CRA and follow-up of missing data, pending queries, SDV backlog, visit schedule, PD, etc.;
- Establish and maintain effective project/site communication.;
- Assist leads in maintenance of internal systems, databases, tracking tools and project plans.;
- Manage the operational insight of the assigned sites/studies and complete the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.).;
- Perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria/ IP/AE/ Labs/EOT/EOS/ End points/SAEs etc.). Review any other information as necessary to determine overall readiness of the patient information for next level review.;
- Perform Study specific analytics based on applicable study specific plans.
- Perform assigned access management related administrative tasks to support team members with project execution, example of tasks includes but not limited to processing access requests, following up with relevant vendors, assigning catalog task to process associates, etc.;
- Act as a backup for Centralized Monitors/Sr. Centralized Monitors.;
- Provide support to the technical solution specialist (TSS) on formulations in Excel, automations of tool using macros codes and designing of the tool on the front end and back end.;
- Facilitating early identification of site-level risk/issue(s) occurring during study conduct and responsible for identification of risk
- Monitor site performance and make recommendations for timely corrective actions (eg Site Telephone Contact or Triggered Onsite Monitoring Visit)
- Review the effectiveness of the recommended actions and take appropriate additional actions if no effect is observed
- Review of the Study Central Monitoring Plan
- Adhere to the key activities outlined in the SOW as per customer requirements

**Qualifications**:

- Other Graduate/Post Graduate in Life Sciences or related field.
- Requires minimum of 2 to 5 years of work experience with minimum of 1 year relevant experience.
- r equivalent combination of education, training and experience. Experience level may vary based on customer specific requirements.
- Good knowledge of applicable clinical research regulatory requirements.
- i.e., International Conference on Harmonisation - Good Clinical Practice and relevant local laws, regulations and guidelines.
- Proficient in Clinical Systems (good knowledge on electronic data capture (EDC), interactive X response system (IXRS), clinical trial management system (CTMS) or equivalent systems).
- Experience of managing global phase trials and clinical trial systems and/or reviewing clinical trial data.
- Strong written and verbal communication skills including good command of English language.
- Results and detail-oriented approach to work delivery and output.
- Good problem-solving skills. - Good planning, time management and prioritization skills.
- Attention to detail and accuracy in work.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Strong telecommunication skills.
- Good data entry skills.

  • Retail Store Manager

    2 days ago

    kochi, India White Force Full time

    Job Description: Role Responsibilities▪ Responsible for overall performance of the Studio – Business performance, Operational excellence, People & Process relatedmatters.▪ Business performance – Achieve and exceed targets for key metrics – footfalls, conversions, sales, modular business asapplicable, outbound and B2B business as...

  • SOC L2

    4 weeks ago

    Kochi, India ValueMentor Full time

    **Description**: - As a Senior Security Analyst (Tier 2) you will be responsible for monitoring in-house and client security alerts/incidents while working in shifts. - Primary responsibilities include participating in various incident investigations, creating new detection methodologies and providing expert support to alerting, incident response and...

  • Lab Cent Project Coord 1

    1 month ago

    Kochi, India Novasyte Full time

    Job Overview Managing assigned monitoring responsibilities (simple protocols/ non-protocol tasks) competently, in a timely manner and with quality. Essential Functions - Under mínimal supervision perform centralized monitoring activities for the assigned projects which includes but is not limited to - On time completion of assigned role specific trainings...

  • System and Website Administrator

    4 weeks ago

    Kochi, India Kerala Shipping and Inland Navigation Corporation Ltd. Full time

    KERALA SHIPPING AND INLAND NAVIGATION CORPORATION LTD - (A Government of Kerala Undertaking)_ - 63/3466, Udaya Nagar Road, Gandhi Nagar, Kochi -682020._ - Tel: 0484 2203614/2206841, Fax 2206848_ No. A-524/2024 Dated 24.01.2024 **Applications are invited for the Post of System &Website Administrator** No of vacancy and nature of appointment-One - Contract...

  • Chef

    1 month ago

    Kochi, India Nanik Food Pvt. ltd. Full time

    Having Experienced for the above 20yrs and above in Arabic Cuisine with Gulf Experience.Must have experience and expertise in Shawarma marinade, processing, stacking, and slicing with the capability to train and control our staff.Must be an expert in BBQs and train and control staff, esp techniques for making BBQs juicer and soft too.Must be an expert in...

  • Am

    4 weeks ago

    Kochi, India TATA Capital Full time

    TCFSL - Shared Services Business Vertical: Shared Services Department: RCU Designation: Manager Line of Business: Shared Services Key Objective of the Job: Verifications of documents - Verification of loan documents through empaneled agencies for ensuring curtailing of fraud at entry level. Background / Profile checks-Checks on profile of customer /...

  • System Engineer

    3 weeks ago

    Kochi, India WORKSENT Full time

    Location: Kochi (Work from Office)Responsibilities & Duties:Managing and troubleshooting active directory and GPO's (Windows server 2012/2016).Managing and troubleshooting Microsoft Exchange server/Office 365.Maintain and administer computer networks and related computing environments including computer hardware, systems software, applications software, and...

  • System Engineer

    3 weeks ago

    Kochi, India WORKSENT Full time

    Location: Kochi (Work from Office)Responsibilities & Duties:Managing and troubleshooting active directory and GPO's (Windows server 2012/2016).Managing and troubleshooting Microsoft Exchange server/Office 365.Maintain and administer computer networks and related computing environments including computer hardware, systems software, applications software, and...

  • Senior Finance Manager

    1 month ago

    kochi, India CONNECTING 2 WORK Full time

    Responsibilities: Preparation of financial statements in accordance with Indian Accounting Standards. Ensure quality control over financial transactions and financial reporting. Co-ordinate with external auditors for statutory audit. Prepare, examine, and analyse accounting records, periodical MIS, etc. Managing and overseeing accounting...

  • BO/BOBJ Administrator

    1 month ago

    kochi, India SPG Consulting Solutions Pvt.Ltd Full time

    Role- Admin. Required Technical Skill Set- BOBJ. Must-Have- (Ideally should not be more than 3-5). - Must have 6+ years of IT experience with at least 80% of admin. experience all through career. - Skilled in BO Administration, Installation, Server management,Patch Upgradations, Users & Groups management and Content management.- Have good knowledge in BO...

  • BO/BOBJ Administrator

    2 weeks ago

    Kochi, India SPG Consulting Solutions Pvt.Ltd Full time

    Role- Admin. Required Technical Skill Set- BOBJ. Must-Have- (Ideally should not be more than 3-5). - Must have 6+ years of IT experience with at least 80% of admin. experience all through career. - Skilled in BO Administration, Installation, Server management,Patch Upgradations, Users & Groups management and Content management.- Have good knowledge in BO...

  • Virtual Relationship Banking-cop Officer

    4 weeks ago

    Kochi, India HDFC Bank Full time

    Department- Classic on Phone- Job posted on- Feb 21, 2024- Employee Type- Permanent-Sales Vertical- Experience range (Years)- 0 - 2 years**Group Company**: HDFC Bank Limited **Designation**: Virtual Relationship Banking-COP Officer **Position description**: Ensuring that customers get world-class services and their needs are understood and met through...

  • Business Coordinator

    4 days ago

    Kochi, Kerala, India SANGEETH NIDHI LIMITED Full time

    Job Summary: As a Business Coordinator for our Gold Loan Division, you will play a pivotal role in ensuring the smooth functioning and growth of our operations across our 12 branches. You will be responsible for coordinating various aspects of the gold loan business, from customer relationship management to operational efficiency and strategic planning. Key...

  • Network Engineer

    1 month ago

    kochi, India SPG Consulting Solutions Pvt.Ltd Full time

    About the job :Network Engineer / Network Security, Check Point/Cisco/Juniper Firewall solution provisionRequirements / Qualifications / Task :- Partner with vendors to select appropriate technical solutions.- Develop state of the art technology appropriate to deliver stable and scalable technical solutions.- Collaborate with stakeholders to develop...

  • BO/BOBJ Administrator

    2 weeks ago

    Cochin/Kochi/Hyderabad/Bangalore/Gurgaon/Gurugram/Noida/Bhubaneshwar, India SPG Consulting Solutions Pvt.Ltd Full time

    Role- Admin. Required Technical Skill Set- BOBJ. Must-Have- (Ideally should not be more than 3-5). - Must have 6+ years of IT experience with at least 80% of admin. experience all through career. - Skilled in BO Administration, Installation, Server management,Patch Upgradations, Users & Groups management and Content management.- Have good knowledge in BO...

  • BO/BOBJ Administrator

    4 weeks ago

    Cochin/Kochi/Hyderabad/Bangalore/Gurgaon/Gurugram/Noida/Bhubaneshwar, IN SPG Consulting Solutions Pvt.Ltd Full time

    Role- Admin. Required Technical Skill Set- BOBJ. Must-Have- (Ideally should not be more than 3-5). - Must have 6+ years of IT experience with at least 80% of admin. experience all through career. - Skilled in BO Administration, Installation, Server management,Patch Upgradations, Users & Groups management and Content management.- Have good knowledge in BO...

  • Network Engineer

    2 weeks ago

    Bangalore/Chennai/Hyderabad/Pune/Cochin/Kochi, India SPG Consulting Solutions Pvt.Ltd Full time

    About the job :Network Engineer / Network Security, Check Point/Cisco/Juniper Firewall solution provisionRequirements / Qualifications / Task :- Partner with vendors to select appropriate technical solutions.- Develop state of the art technology appropriate to deliver stable and scalable technical solutions.- Collaborate with stakeholders to develop...

  • Network Engineer

    4 weeks ago

    Bangalore/Chennai/Hyderabad/Pune/Cochin/Kochi, IN SPG Consulting Solutions Pvt.Ltd Full time

    About the job :Network Engineer / Network Security, Check Point/Cisco/Juniper Firewall solution provisionRequirements / Qualifications / Task :- Partner with vendors to select appropriate technical solutions.- Develop state of the art technology appropriate to deliver stable and scalable technical solutions.- Collaborate with stakeholders to develop...