Manager, Clinical Development

SERB • Conshohocken, PA

4d

About The Position

The Manager, Clinical Development is accountable for the overall operation of clinical studies across the product portfolio, including project planning, budgeting, resource management, and contact with contract research organizations. The role operates within approved clinical operational plans and supports lifecycle program and company goals.

The position manages company-sponsored and investigator-initiated studies in compliance with company SOPs, clinical protocols, Good Clinical Practice, and applicable regulations. It oversees outsourced services and vendor relationships, drafts study documents, manages study budgets and site documentation, and works with legal teams and sites to negotiate investigator-initiated study contracts. The role also maintains knowledge of relevant FDA, ICH, and GCP requirements and supports other clinical-function tasks as required by the Line Manager.

Requirements

• University degree in a health-related field.
• At least three years of direct clinical trial experience in a CRO or research-related organization.
• Ability to work confidently and independently as well as collaboratively in a team.
• Knowledge of the clinical research process from Phase I through regulatory submission.
• Strong verbal and written communication skills, including the ability to express complex ideas.
• Excellent organizational and interpersonal skills.
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
• Ability to manage multiple priorities across various clinical trials.
• Ability to reason independently and assess and recommend solutions in clinical settings.
• Ability to set baseline targets, track trends, and implement mitigation plans.
• Understanding of basic data-processing functions, including electronic data capture.
• Working knowledge of current ICH GCP guidelines.

Nice To Haves

• Previous experience with in-vitro diagnostic studies.
• EU experience.
• Experience in contract and timeline management.

Responsibilities

• Manage company-sponsored and investigator-initiated studies in accordance with company SOPs, ensuring compliance with internal procedures and external regulations.
• Ensure assigned clinical research projects comply with the clinical protocol, current Good Clinical Practice requirements, and other applicable regulations.
• Oversee outsourced tasks and services and manage contractor relationships to maintain appropriate vendor oversight.
• Draft study documents, including synopses, study protocols, informed consents, and study plans, in accordance with company SOPs.
• Prepare clinical study budgets and manage studies within approved budgets.
• Ensure regulatory documents are obtained from study sites and study files are established and maintained in accordance with GCP and relevant SOPs.
• Update and draft SOPs as required.
• Work with legal teams and study sites to negotiate contracts for investigator-initiated studies.
• Maintain current knowledge of FDA regulations, GCP, and ICH Guidelines for clinical research.
• Carry out interactions and engagements to high ethical and professional standards, delivering quality work in accordance with BTG values.
• Perform other reasonable additional tasks as required by the Line Manager to support clinical functions.

Benefits

• Vacation, personal, and sick time.
• 15 paid company holidays.
• Medical, dental, vision, and other voluntary benefits.
• Paid parental leave.
• Tuition assistance.
• Discretionary bonus plan.
• Competitive 401(k) match: $1 for $1 up to 6% of pay, with the safe-harbor match immediately vested; an additional discretionary match of up to 4% of pay vests 20% per year over five years.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager