Job Description

Job Title	Clinical Trial Lead / Clinical Trial Manager
Reports to	CEO
Department	Business Development
Location	Remote
Supervises	All activities related to various projects and general departmental activities.
Job Type	Contract

Company Overview

Credevo is a global consulting organization supporting healthcare product development from clinical development to commercialization. Credevo provides strategic support in areas such as regulatory, clinical development, licensing (out-/in-), and feasibility support, for products including pharmaceuticals, biologics, nutraceuticals, and medical devices.

Position Overview

This is a remote position reporting to the company management. The role will be clinical trial
lead / Clinical Trial Manager who can effectively lead, supervise, and manage all activities
related to various projects and general departmental activities.

Experience:

Sites and investigators relations: Develop, consolidate, expand, and manage
Credevo’s relationship with its current global network of sites and investigators by

At least 5 years of overall clinical trial experience- out of which
a. at least 2 years should be in on-site visits based trial monitoring, in a minimum of
2 trial projects and
b. at least 1 year should be as clinical trial lead or clinical trial manager across a
minimum of 2 projects

Candidates with significant experience in building and maintaining site- / investigatorrelations will be preferred.

Experience in sponsor facing roles will be an added advantage.
Responsibilities:
Essential duties and responsibilities include but are not limited to the following:

Client communication: Communicate and coordinate with customers to understand
their needs for clinical trials, evaluate product details, business needs, and customer
requirements to
a. identify the study rationale,
b. identify key geographic regions for the trial,
c. prepare a strategic plan for the trial and advise on the way forward

Trial management: Lead, supervise, and manage clinical trial projects across sites in
Asia-Pac, the US, and India locations, including but not limited to
a. Development of internal and external trial teams,
b. Study document development and finalization
c. Feasibility assessment and site selection
d. Other study start-up activities, such as RA and ethics submission
e. Selection and management of relations with sites, investigators, and vendors
f. Clinical operations, including monitoring and site management leading to
completion of data entry and data management activities up to database lock

3. Sites and investigators relations: Develop, consolidate, expand, and manage
   Credevo’s relationship with its current global network of sites and investigators by:

a. Strengthening connectivity to and communications with more than 150,000
investigators across the world
b. Building systems and processes to evaluate clinical trial feasibility
c. Identifying key needs of sites and investigators in Credevo’s network
d. Developing solutions to support investigators

Management support: Work with company management and provide required support
in all clinical trial-related areas, including but not limited to
a. Development and implementation of key tools, systems, and study processes
such as SOPs, and quality control measures.
b. Maintaining comprehensive and up-to-date knowledge of relevant regulations,
guidelines, and best practices in clinical research.
c. Undertaking key initiatives to improve the current status of clinical research and
other management drives in organizational development
d. Ensuring timely reporting to the management team and relevant stakeholders.

Qualifications:

1. At least a graduate, preferably in life sciences, healthcare, pharmaceutical or medical
   streams.
2. Trained and expert in ICH Good Clinical Practice (GCP) and regulatory processes.

Skills & Abilities:

1. Trained and ready to work in a global environment and flexible to work across multiple
   time zones.
2. Advanced knowledge of working in Google Suite / Microsoft Office Suite (Word, Excel,
   SharePoint, Teams, etc.) as well as electronic documentation systems.
3. Demonstrated ability to lead teams and prepare organizational strategies, especially for
   clinical trial management
4. Quick learner and work well without constant supervision.
5. Ability to understand and comprehend the needs of the work and cooperate well.

Language Proficiency:

1. Expert in written communication skills in the English language – This should be
   demonstrated by prior work and on-the-spot tests (during the selection process).
2. Good English speaking skills with the ability to understand different international
   accents are also required.

IMPORTANT: You will need to login to your gmail / google account for authentication to apply.