Careers

KlinEra is a rapidly growing organization in the dynamic global clinical research market with a focus on clinical trials in India.

By joining the team at KlinEra, you'll have the ability to shape the trajectory of a fast growing company where you will directly impact your career by participating in all phases of clinical research studies for some of the largest Biotech and Pharmaceutical companies in the world.

Working at KlinEra means you share our passion for monitoring the pulse of the latest developments in clinical research practices and bringing innovative and cutting edge therapeutic solutions to the communities that we live and work in.

We take pride in creating a friendly, challenging and fast-paced environment with significant autonomy, responsibility and ownership.

KlinEra has corporate offices in San Jose, CA and Mumbai, India.

Current Openings:

Open Positions

Senior Manager/Director of Global Clinical Trials

Location: San Jose, CA

Position: Full time

KlinEra is looking for a seasoned clinical trial project manager to take charge and be responsible for the oversight of all clinical trial projects within the company. This is a full-time contract position and will be located at our San Jose, CA office.

The Role:

As the Senior Clinical Trial Project Manager, you will work directly with the President of Global Clinical Operations to oversee the company’s entire clinical trial portfolio and be responsible for oversight, management and all related protocols of the clinical trial process. You must have proven experience in managing global clinical trials with a specific focus in Southeast Asia a big plus. This is a senior management while highly autonomous role that requires a self-motivated, proactive and experienced individual ready to hit the ground running.

This position will also work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH, GCP, regulatory guidelines, company goals, and budgets.

RESPONSIBILITIES:

  • Establish appropriate clinical tools and processes for the study team to support the execution of clinical deliverables and study timelines
  • Manage clinical study set-up and follow-up study activities through ongoing tracking and review of study progress
  • Collaborate with other functional groups within the company such as data management, pharmacovigilance, and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles
  • Provide ongoing training and support to the clinical team
  • Establish study tools and training materials
  • Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring /accompanied site visits and ongoing mentoring of CRA team
  • Track clinical budget consumption through regular review of project budget reports
  • Liaison with study sponsors
  • Monitor ongoing compliance to study protocols, FDA regulations, and IRB requirements
  • Prepare technical and scientific publications
  • Prepare accurate and timely reports to management

REQUIREMENTS:

  • BS preferred in Pharmacy or other medical discipline
  • Minimum 5-8 years experience in the clinical research industry
  • Minimum 3-5 years project management experience managing teams and direct reports
  • Proven experience managing global clinical trials – Southeast Asia a big plus
  • Knowledge of FDA and International regulatory requirements
  • Excellent written and verbal communication skills
  • May require travel up to 20% of time

Clinical Trial Project Manager

Location: Mumbai, India

Position: Full time

The clinical trial project manager will play a critical role on our team and be responsible for various aspects of KlinEra's global clinical trials in Mumbai, India. This is an autonomous role that requires a self-motivated, proactive and experienced individual ready to hit the ground running.

This position will also work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH, GCP, regulatory guidelines, company goals, and budgets.

In this role you will assist with the preparation of protocols and case report forms, finalization of monitoring and data management, and ensure the seamless integration of the clinical research team in all necessary capacities.

RESPONSIBILITIES:

  • Managing a clinical project team
  • Managing clinical research sites
  • Executing clinical protocols
  • Oversee proper collection of data
  • Liaison with the study sponsor
  • Monitor ongoing compliance to study protocols, FDA regulations, and IRB requirements
  • Manage clinical research associates
  • Work with management to implement department policies and procedures
  • Participate in the preparation of technical and scientific publications
  • Preparing accurate and timely reports to management
  • Assist in the development and maintenance of computerized data collection system
  • Complete projects and tasks in a manner consistent with corporate objectives and meet study timelines

REQUIREMENTS:

  • BS preferred in Pharmacy or other medical discipline
  • Minimum 4 years experience in the clinical research industry
  • Minimum 2 years project management experience managing teams and direct reports
  • Knowledge of FDA and International regulatory requirements
  • Excellent written and verbal communication skills
  • May require travel up to 30% of time

Senior Clinical Trial Project Manager

Location: Mumbai, India

Position: Full time

The Senior Clinical Trial Project Manager will play a critical role on our team and be responsible for various aspects of KlinEra's global clinical trials in Mumbai, India in a leadership capacity.
This is a senior leadership position and highly autonomous role that requires a self-motivated, proactive and experienced individual ready to hit the ground running.
This position will also work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH, GCP, regulatory guidelines, company goals, and budgets.

In this role you will oversee and assist with the preparation of protocols and case report forms, finalization of monitoring and data management, and ensure the seamless integration of the clinical research team in all necessary capacities.

RESPONSIBILITIES:

  • Managing a clinical project team
  • Managing clinical research sites
  • Executing clinical protocols
  • Oversee proper collection of data
  • Liaison with the study sponsor
  • Monitor ongoing compliance to study protocols, FDA regulations, and IRB requirements
  • Manage clinical research associates
  • Work with management to implement department policies and procedures
  • Participate in the preparation of technical and scientific publications
  • Preparing accurate and timely reports to management
  • Assist in the development and maintenance of computerized data collection system
  • Complete projects and tasks in a manner consistent with corporate objectives and meet study timelines

REQUIREMENTS:

  • BS preferred in Pharmacy or other medical discipline
  • Minimum 5 years experience in the clinical research industry
  • Minimum 3 years project management experience managing teams and direct reports
  • Knowledge of FDA and International regulatory requirements
  • Excellent written and verbal communication skills
  • May require travel up to 30% of time