Skip to content

Open nowPosted 59 days ago

Clinical Trial Manager

Skyhawk Therapeutics2 open roles

Where
Waltham, MA
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowClinical Trial ManagerSkyhawk Therapeutics · Waltham, MA
  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Skyhawk Therapeutics's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 57.8%60 days
This job: posted 59 days ago

The posting

Clinical Trial Manager

Skyhawk Therapeutics seeks an experienced Clinical Trial Manager (title commensurate with experience) who is looking to work in a fast paced, growth mindset organization focused on developing innovative therapies across a broad portfolio of development candidates. Skyhawk’s preferred candidate will have Clinical Operations experience preferably supporting rare or CNS trials in a biotech/small pharma setting to join our Clinical Operations group.

Responsibilities:

  • Manage execution of the clinical study in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/Work Instructions
  • Development, management, maintenance of study deliverables [i.e. protocols, informed consents, timelines, study plans, etc.] through collaboration with internal and external stakeholders
  • Participation in Vendor and system selection (as applicable), specification development, and management/oversight of key trial vendor/system deliverables, including developing and managing to contracts and budgets
  • Management of study training for study team, investigational sites, and vendors in collaboration with medical and scientific colleagues
  • Contribute to cross functional deliverables across the study team internally. Ensuring timely information sharing and inclusion of relevant expertise areas to deliver trial results on time, efficiently and effectively
  • Assist in managing CRO and other study vendors day-to-day activities working directly with the CRO or vendor trial management team, ensuring contracted deliverables are achieved on time and on budget
  • Contribute to development of proactive strategy to enable timely delivery of study objectives, including but not limited to enrollment projections, cohort planning, identification of potential challenges in study execution and risk management
  • Ensure execution of study in a GxP compliant manner by working closely with QA to develop (as applicable) corrective and preventive action plans (CAPAs) to address trial issues in collaboration with cross functional team
  • Responsible for supporting the management, oversight and maintenance of the Trial Master File (TMF)
  • Contribute to growth and development of clinical operations function via process/SOP review and process improvement initiatives

Requirements, Education, Experience & Skills:

  • Bachelor’s degree, or equivalent, in a biomedical, life science or related field of study
  • Minimum of 5+ years of progressively increasing Clinical Operations experience within the biotech/pharma industry; Rare disease or CNS experience preferred (title commensurate with experience)
  • Strong understanding of Global regulatory and ICH-GCP compliance requirements for clinical research
  • Solid teamwork, organizational, interpersonal, and problem-solving skills
  • Ability to influence and collaborate well with colleagues and partners in a fast-paced environment
  • Proven track record (>2 years) of successful remote work in clinical operations if unable to be onsite
  • Ability and willingness to travel up to 25% of time

Skyhawk Therapeutics is committed to pay transparency and equitable compensation practices. The base salary range for the Clinical Trial Manager is $140,000-200,000 annually. This range reflects the minimum and maximum target for such position. Skyhawk Therapeutics will assess the appropriate level for a qualified candidate based on job-related skills, professional experience, and relevant education or training.

About Skyhawk

Skyhawk is committed to discovering, developing and commercializing small molecule therapeutics that modify RNA expression. We use our novel SkySTAR® platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed toward targets for some of the world’s most intractable diseases including neurological conditions, cancer, and traditionally “undruggable” targets.

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against Skyhawk Therapeutics's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.
  3. We apply on Skyhawk Therapeutics's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.
  4. Every reply, sorted

    Skyhawk Therapeutics's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.
  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.