Senior Trial Manager - FS

This

position

is

listed

on

behalf

of

a

partner

company,

which

manages

all

applications

and

next

steps.

Our

partner

is

looking

for

a

Senior

Trial

Manager

-

FS

based

in

the

United

States

.

The

Senior

Trial

Manager

will

provide

strategic

leadership

and

operational

oversight

for

clinical

trials,

ensuring

studies

are

delivered

successfully

from

planning

through

completion.

This

role

offers

the

opportunity

to

collaborate

with

biotech,

medtech,

and

specialty

pharmaceutical

organizations

developing

innovative

treatments

and

medical

technologies.

You

will

lead

global

clinical

trial

operations,

coordinate

cross-functional

teams,

and

ensure

compliance

with

applicable

regulatory

standards

and

Good

Clinical

Practice

(GCP).

Working

closely

with

sponsors,

clinical

research

teams,

investigative

sites,

and

external

vendors,

you

will

drive

study

quality,

timelines,

and

budget

performance.

The

position

focuses

on

therapeutic

areas

including

rare

dermatology,

immunology,

inflammation,

and

autoimmune

diseases.

This

is

an

exciting

opportunity

to

contribute

to

meaningful

medical

advancements

while

working

in

a

flexible,

remote

environment

that

values

collaboration,

professional

development,

and

patient

impact.

Accountabilities

Lead

and

oversee

the

planning,

execution,

and

completion

of

clinical

trials,

ensuring

compliance

with

applicable

regulations,

guidelines,

and

ICH/GCP

standards.

Coordinate

and

manage

clinical

trial

operations

teams,

ensuring

effective

collaboration,

milestone

achievement,

and

successful

project

delivery.

Oversee

the

development,

review,

and

maintenance

of

essential

clinical

trial

documentation,

including

Case

Report

Forms

(CRFs),

source

documents,

templates,

and

study

plans.

Contribute

to

protocol

and

study

design

reviews,

informed

consent

documentation,

and

provide

operational

guidance

to

Clinical

Research

Associates

(CRAs)

and

investigative

sites.

Develop

and

maintain

study-specific

Clinical

Monitoring

Plans

(CMPs),

incorporating

clear

communication,

escalation

procedures,

and

appropriate

follow-up

actions.

Lead

clinical

operations

activities

related

to

the

evaluation,

selection,

and

management

of

investigative

sites

and

external

vendors,

including

central

laboratories

and

interactive

voice

response

systems

(IVRS).

Drive

successful

site

activation

while

ensuring

clinical

trials

remain

aligned

with

established

timelines,

quality

expectations,

scope,

and

budgets.

Manage

and

monitor

clinical

monitoring

teams,

ensuring

high-quality

deliverables

and

timely

execution

of

study

activities.

Review

clinical

data

reports

and

monitoring

visit

documentation

to

optimize

monitoring

activities

and

maintain

quality

standards.

Build

strong

relationships

with

sponsors

and

stakeholders,

proactively

addressing

operational

challenges

and

ensuring

a

positive

customer

experience.

Requirements

Bachelor's

degree

or

international

equivalent

from

an

accredited

institution,

preferably

in

clinical,

biological,

scientific,

or

healthcare-related

disciplines,

or

an

equivalent

combination

of

education,

training,

and

experience.

At

least

10

years

of

clinical

research

experience,

including

a

minimum

of

7

years

overseeing

global

clinical

studies

and

managing

CRO

activities

on

behalf

of

sponsors.

Demonstrated

therapeutic

experience

in

rare

dermatology,

immunology,

inflammation,

and/or

autoimmune

disease

areas.

Strong

knowledge

of

clinical

trial

management,

global

study

oversight,

regulatory

requirements,

and

ICH/GCP

guidelines.

Proven

ability

to

manage

complex

clinical

research

projects,

coordinate

multidisciplinary

teams,

and

deliver

milestones

within

established

timelines

and

budgets.

Experience

overseeing

clinical

monitoring

activities,

investigative

site

selection

and

activation,

vendor

management,

and

study

documentation.

Excellent

written

and

verbal

communication

skills

in

English,

with

the

ability

to

engage

effectively

with

sponsors,

investigative

sites,

and

internal

stakeholders.

Strong

analytical,

organizational,

and

How Jobgether works

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• We appreciate your interest and wish you the best!
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