Clinical Trial Manager

Wage:
Job Description

Function: Director of Scientific Trials

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Acorn Biolabs is a personalised regenerative medication firm enabling people to leverage the ability of their very own cells in cosmetics, harm restoration and basic well being.

First, we provide a cell preservation service. As we age, so do our cells; over time, they grow to be extra broken and fewer succesful. Which means once we want our cells essentially the most, they might be too outdated and ineffective to obtain the complete advantages of regenerative therapies.

Acorn helps with this. We offer an answer to permit people to gather and cryogenically freeze their very own cells, sourced non-invasively from hair follicles. This halts the consequences of growing old, offering you with a group of your individual youthful cells, prepared for the way forward for regenerative medication.

Subsequent, Acorn not solely acts as your cell cryopreservation useful resource however can also be actively growing cell-based therapies, first in cosmetics and shortly generally well being. Now we have lately launched our companies by partnering with Dermatologists, Plastic Surgeons, MedSpas, and Wellness Facilities throughout North America.

The Function

We’re in search of a extremely motivated and skilled Director of Scientific Trials reporting to our CEO to affix our dynamic staff. As a Director of Scientific Trials at Acorn Biolabs, you’ll play an important position in managing and overseeing the profitable execution of our single-site research targeted on cosmetics in addition to medical trials targeted on aesthetic medication and shortly basic well being, whereas making certain compliance with regulatory pointers and sustaining the very best requirements of high quality and ethics.

Our values are vital to us and set the tradition of our firm.

Integrity first

In our science, with our purchasers, with one another. All the time.

Collaborate

Be variety, supportive, respectful, and inclusive. Be humble and grateful.

Present up

Take delight in your work. Be reliable, accountable, and disciplined. Try for excellence – and be agile. Add worth.

Be curious

Ask why. Always be taught. Create. Innovate.

Have enjoyable

Take pleasure in life! Chortle – at your self and with others. Be enthusiastic about your work.

Location: Toronto / Los Angeles / Distant work preparations doable

What You may Do

Trial Planning and Design:
Collaborate with cross-functional groups to develop and refine trial protocols, making certain scientific rigor and alignment with strategic aims – particularly within the cosmetics and aesthetics area.

Create detailed undertaking plans, together with timelines, milestones, and useful resource allocation, to make sure well timed execution of trials.

Take part in examine feasibility assessments and supply enter on recruitment methods.

Examine Oversight and Administration:
Function the first level of contact for inside and exterior stakeholders concerned in trials, together with clinic companions, investigators, examine websites, contract analysis organizations (CROs), and regulatory authorities.

Coordinate and conduct affected person interviews and surveys.

Monitor and supervise examine progress, making certain adherence to protocols, regulatory necessities, and Good Scientific Follow (GCP) pointers.

Handle and evaluate study-related documentation, akin to knowledgeable consent kinds, case report kinds, and examine studies, with a give attention to the distinctive necessities of cosmetics and aesthetics trials.

Conduct common website visits and/or coordinate monitoring actions to make sure information integrity, security, and regulatory compliance.

Regulatory Compliance and Collaboration:
Collaborate with regulatory authorities, such because the FDA and Well being Canada, to make sure compliance with relevant laws and pointers for cosmetics and aesthetics medical trials.

Help within the preparation and submission of regulatory paperwork particular to cosmetics and aesthetics trials, together with Investigational New Drug (IND) functions, Ethics Committee/Institutional Assessment Board (IRB) submissions, and security studies.

Set up and preserve efficient working relationships with regulatory authorities to facilitate the approval course of and guarantee regulatory compliance all through the trials.

Crew Management and Collaboration:
Foster a optimistic and collaborative work setting, selling open communication and information sharing inside the medical operations staff.

Present steerage and assist to staff members, making certain their skilled improvement and adherence to firm and trade requirements particular to cosmetics and aesthetics trials.

Danger Evaluation and Mitigation:
Establish potential dangers and points particular to cosmetics and aesthetics trials throughout planning and execution phases, growing mitigation methods and contingency plans as wanted.

Implement danger administration processes, together with the evaluation, monitoring, and determination of study-related points within the cosmetics and aesthetics discipline.

Foster a tradition of security and moral conduct, prioritizing affected person welfare and regulatory compliance all through the medical trial course of.

What You may Want To Succeed

Grasp of Science (MS) or Physician of Philosophy (PhD) diploma in Scientific Drugs, Biology, Microbiology, Biochemistry, or associated areas.

Minimal of 5 years of expertise in medical trial administration inside the pharmaceutical, biotechnology, or CRO trade, with a give attention to cosmetics and aesthetics trials most popular.

In-depth information of cosmetics and aesthetics medical trial laws, GCP pointers, and trade greatest practices.

Earlier expertise speaking instantly with regulatory our bodies (eg. FDA, cFDA, Well being Canada) is most popular.

Robust understanding of medical trial methodologies, examine design, and statistical ideas within the cosmetics and aesthetics discipline.

Glorious management and staff administration abilities, with the power to encourage and encourage cross-functional groups.

Efficient communication and interpersonal abilities, with the power to construct sturdy relationships with inside and exterior stakeholders, together with regulatory authorities.

Confirmed problem-solving and decision-making skills, with the capability to adapt to altering priorities and deal with advanced conditions.

Certification in medical analysis (e.g., CCRA, CCRP) is a plus.

Dedication to main with humility, curiosity, and transparency, with a willingness to roll up your sleeves and dig into the work

Why Acorn

In our lifetime, our personal cells would be the key to fixing a few of the greatest healthcare challenges. Offering everybody with the very best alternative to reside longer, keep lively, and really feel higher. We’re excited by the potential the longer term will convey.

Acorn Biolabs presents a aggressive wage and advantages package deal, together with medical insurance, Dental, and alternatives for skilled development. Be part of our revolutionary and passionate staff, and contribute to groundbreaking developments in customized medication by means of mobile preservation within the cosmetics and aesthetics discipline.

Be part of the Acorn staff and be a part of one thing nice!